Systems, devices, and methods including catheters having an actively controllable therapeutic agent delivery component

ABSTRACT

Systems, devices, methods, and compositions are described for providing an actively-controllable disinfecting implantable device configured to, for example, treat or prevent an infection in a biological subject.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is related to and claims the benefit of theearliest available effective filing dates from the following listedapplications (the “Related applications”) (e.g., claims earliestavailable priority dates for other than provisional patent applicationsor claims benefits under 35 U.S.C. §116(e) for provisional patentapplications, for any and all parent, grandparent, great-grandparent,etc. applications of the Related applications). All subject matter ofthe Related applications and of any and all parent, grandparent,great-grandparent, etc. applications of the Related applications isincorporated herein by reference to the extent such subject matter isnot inconsistent herewith.

RELATED APPLICATIONS

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/315,880,titled SYSTEM, DEVICES, AND METHODS INCLUDING ACTIVELY-CONTROLLABLESUPEROXIDE WATER GENERATING SYSTEMS, naming Edward S. Boyden; Ralph G.Dacey, Jr.; Gregory J. Della Rocca; Joshua L. Dowling; Roderick A. Hyde;Muriel Y. Ishikawa; Jordin T. Kare; Eric C. Leuthardt; Nathan P.Myhrvold; Dennis J. Rivet; Paul Santiago; Michael A. Smith; Todd J.Stewart; Elizabeth A. Sweeney; Clarence T. Tegreene; Lowell L. Wood,Jr.; and Victoria Y. H. Wood as inventors, filed 4 Dec. 2008, now U.S.Pat. No. 8,162,924 or is an application of which a currently co-pendingapplication is entitled to the benefit of the filing date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/315,881,titled SYSTEM, DEVICES, AND METHODS INCLUDING STERILIZING EXCITATIONDELIVERY IMPLANTS WITH CRYPTOGRAPHIC LOGIC COMPONENTS, naming Edward S.Boyden; Ralph G. Dacey, Jr.; Gregory J. Della Rocca; Joshua L. Dowling;Roderick A. Hyde; Muriel Y. Ishikawa; Jordin T. Kare; Eric C. Leuthardt;Nathan P. Myhrvold; Dennis J. Rivet; Paul Santiago; Michael A. Smith;Todd J. Stewart; Elizabeth A. Sweeney; Clarence T. Tegreene; Lowell L.Wood, Jr.; and Victoria Y. H. Wood as inventors, filed 4 Dec. 2008,which is currently co-pending or is an application of which a currentlyco-pending application is entitled to the benefit of the filing date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/315,882,titled SYSTEM, DEVICES, AND METHODS INCLUDING STERILIZING EXCITATIONDELIVERY IMPLANTS WITH GENERAL CONTROLLERS AND ONBOARD POWER, namingEdward S. Boyden; Ralph G. Dacey, Jr.; Gregory J. Della Rocca; Joshua L.Dowling; Roderick A. Hyde; Muriel Y. Ishikawa; Jordin T. Kare; Eric C.Leuthardt; Nathan P. Myhrvold; Dennis J. Rivet; Paul Santiago; MichaelA. Smith; Todd J. Stewart; Elizabeth A. Sweeney; Clarence T. Tegreene;Lowell L. Wood, Jr.; and Victoria Y. H. Wood as inventors, filed 4 Dec.2008, now abandoned or is an application of which a currently co-pendingapplication is entitled to the benefit of the filing date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/315,883,titled SYSTEM, DEVICES, AND METHODS INCLUDING ACTIVELY-CONTROLLABLEELECTROMAGNETIC ENERGY-EMITTING DELIVERY SYSTEMS AND ENERGY-ACTIVATABLEDISINFECTING AGENTS, naming Ralph G. Dacey, Jr., Roderick A. Hyde,Muriel Y. Ishikawa, Jordin T. Kare, Eric C. Leuthardt, Nathan P.Myhrvold, Dennis J. Rivet, Michael A. Smith, Elizabeth A. Sweeney,Clarence T. Tegreene, and Lowell L. Wood, Jr., Victoria Y. H. Wood asinventors, filed 4 Dec. 2008, which is currently co-pending or is anapplication of which a currently co-pending application is entitled tothe benefit of the filing date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/315,884,titled SYSTEM, DEVICES, AND METHODS INCLUDING ACTIVELY-CONTROLLABLESTERILIZING EXCITATION DELIVERY IMPLANTS, naming Edward S. Boyden, RalphG. Dacey, Jr., Gregory J. Della Rocca, Joshua L. Dowling, Roderick A.Hyde, Muriel Y. Ishikawa, Jordin T. Kare, Eric C. Leuthardt, Nathan P.Myhrvold, Dennis J. Rivet, Paul Santiago, Michael A. Smith, Todd J.Stewart, Elizabeth A. Sweeney, Clarence T. Tegreene, Lowell L. Wood,Jr., Victoria Y. H. Wood as inventors, filed 4 Dec. 2008, which iscurrently co-pending or is an application of which a currentlyco-pending application is entitled to the benefit of the filing date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/315,885,titled SYSTEM, DEVICES, AND METHODS INCLUDING ACTIVELY-CONTROLLABLEELECTROSTATIC AND ELECTROMAGNETIC STERILIZING EXCITATION DELIVERYSYSTEM, naming Edward S. Boyden; Ralph G. Dacey, Jr.; Gregory J. DellaRocca; Joshua L. Dowling; Roderick A. Hyde; Muriel Y. Ishikawa; JordinT. Kare; Eric C. Leuthardt; Nathan P. Myhrvold; Dennis J. Rivet; PaulSantiago; Michael A. Smith; Todd J. Stewart; Elizabeth A. Sweeney;Clarence T. Tegreene; Lowell L. Wood, Jr.; and Victoria Y. H. Wood asinventors, filed 4 Dec. 2008, now abandoned or is an application ofwhich a currently co-pending application is entitled to the benefit ofthe filing date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/380,553,titled SYSTEM, DEVICES, AND METHODS INCLUDING ACTIVELY-CONTROLLABLESTERILIZING EXCITATION DELIVERY IMPLANTS, naming Edward S. Boyden; RalphG. Dacey, Jr.; Gregory J. Della Rocca; Joshua L. Dowling; Roderick A.Hyde; Muriel Y. Ishikawa; Jordin T. Kare; Eric C. Leuthardt; Nathan P.Myhrvold; Dennis J. Rivet; Paul Santiago; Michael A. Smith; Todd J.Stewart; Elizabeth A. Sweeney; Clarence T. Tegreene; Lowell L. Wood; andJr.; and Victoria Y. H. Wood as inventors, filed 27 Feb. 2009, which iscurrently co-pending or is an application of which a currentlyco-pending application is entitled to the benefit of the filing date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/592,976,titled SYSTEM, DEVICES, AND METHODS INCLUDING ACTIVELY-CONTROLLABLESTERILIZING EXCITATION DELIVERY IMPLANTS, naming Edward S. Boyden, RalphG. Dacey, Jr., Gregory J. Della Rocca, Joshua L. Dowling, Roderick A.Hyde, Muriel Y. Ishikawa, Jordin T. Kare, Eric C. Leuthardt, Nathan P.Myhrvold, Dennis J. Rivet, Paul Santiago, Michael A. Smith, Todd J.Stewart, Elizabeth A. Sweeney, Clarence T. Tegreene, Lowell L. Wood,Jr., and Victoria Y. H. Wood. as inventors, filed 3 Dec. 2009, which iscurrently co-pending or is an application of which a currently copendingapplication is entitled to the benefit of the filing date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/660,156,titled SYSTEMS, DEVICES, AND METHODS INCLUDING INFECTION-FIGHTING ANDMONITORING SHUNTS, naming RALPH G. DACEY, JR., RODERICK A. HYDE, MURIELY. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, NATHAN P. MYHRVOLD,DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A. SWEENEY, CLARENCE T.TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOOD as inventors, filed19, Feb., 2010, now U.S. Pat. No. 8,366,652 or is an application ofwhich a currently co-pending application is entitled to the benefit ofthe filing date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/800,766,titled SYSTEMS, DEVICES, AND METHODS INCLUDING INFECTION-FIGHTING ANDMONITORING SHUNTS, naming RALPH G. DACEY, JR., RODERICK A. HYDE, MURIELY. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, NATHAN P. MYHRVOLD,DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A. SWEENEY, CLARENCE T.TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOOD as inventors, filed21, May, 2010, now U.S. Pat. No. 8,216,173 or is an application of whicha currently co-pending application is entitled to the benefit of thefiling date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/800,774,titled SYSTEMS, DEVICES, AND METHODS INCLUDING INFECTION-FIGHTING ANDMONITORING SHUNTS, naming RALPH G. DACEY, JR., RODERICK A. HYDE, MURIELY. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, NATHAN P. MYHRVOLD,DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A. SWEENEY, CLARENCE T.TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOOD as inventors, filed21, May, 2010, which is currently co-pending or is an application ofwhich a currently co-pending application is entitled to the benefit ofthe filing date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/800,778,titled SYSTEMS, DEVICES, AND METHODS INCLUDING INFECTION-FIGHTING ANDMONITORING SHUNTS, naming RALPH G. DACEY, JR., RODERICK A. HYDE, MURIELY. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, NATHAN P. MYHRVOLD,DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A. SWEENEY, CLARENCE T.TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOOD as inventors, filed21, May, 2010, now abandoned or is an application of which a currentlyco-pending application is entitled to the benefit of the filing date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/800,779,titled SYSTEMS, DEVICES, AND METHODS INCLUDING INFECTION-FIGHTING ANDMONITORING SHUNTS, naming RALPH G. DACEY, JR., RODERICK A. HYDE, MURIELY. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, NATHAN P. MYHRVOLD,DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A. SWEENEY, CLARENCE T.TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOOD as inventors, filed21, May, 2010, which is currently co-pending or is an application ofwhich a currently co-pending application is entitled to the benefit ofthe filing date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/800,780,titled SYSTEMS, DEVICES, AND METHODS INCLUDING INFECTION-FIGHTING ANDMONITORING SHUNTS, naming RALPH G. DACEY, JR., RODERICK A. HYDE, MURIELY. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, NATHAN P. MYHRVOLD,DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A. SWEENEY, CLARENCE T.TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOOD as inventors, filed21, May, 2010, which is currently co-pending or is an application ofwhich a currently co-pending application is entitled to the benefit ofthe filing date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/800,781,titled SYSTEMS, DEVICES, AND METHODS INCLUDING INFECTION-FIGHTING ANDMONITORING SHUNTS, naming RALPH G. DACEY, JR., RODERICK A. HYDE, MURIELY. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, NATHAN P. MYHRVOLD,DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A. SWEENEY, CLARENCE T.TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOOD as inventors, filed21, May, 2010, now abandoned or is an application of which a currentlyco-pending application is entitled to the benefit of the filing date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/800,786,titled SYSTEMS, DEVICES, AND METHODS INCLUDING INFECTION-FIGHTING ANDMONITORING SHUNTS, naming RALPH G. DACEY, JR., RODERICK A. HYDE, MURIELY. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, NATHAN P. MYHRVOLD,DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A. SWEENEY, CLARENCE T.TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOOD as inventors, filed21, May, 2010, now abandoned or is an application of which a currentlyco-pending application is entitled to the benefit of the filing date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/800,790,titled SYSTEMS, DEVICES, AND METHODS INCLUDING INFECTION-FIGHTING ANDMONITORING SHUNTS, naming RALPH G. DACEY, JR., RODERICK A. HYDE, MURIELY. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, NATHAN P. MYHRVOLD,DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A. SWEENEY, CLARENCE T.TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOOD as inventors, filed21, May, 2010, now U.S. Pat. No. 8,343,086 or is an application of whicha currently co-pending application is entitled to the benefit of thefiling date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/800,791,titled SYSTEMS, DEVICES, AND METHODS INCLUDING INFECTION-FIGHTING ANDMONITORING SHUNTS, naming RALPH G. DACEY, JR., RODERICK A. HYDE, MURIELY. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, NATHAN P. MYHRVOLD,DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A. SWEENEY, CLARENCE T.TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOOD as inventors, filed21, May, 2010, now U.S. Pat. No. 8,282,593 or is an application of whicha currently co-pending application is entitled to the benefit of thefiling date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/800,792,titled SYSTEMS, DEVICES, AND METHODS INCLUDING INFECTION-FIGHTING ANDMONITORING SHUNTS, naming RALPH G. DACEY, JR., RODERICK A. HYDE, MURIELY. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, NATHAN P. MYHRVOLD,DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A. SWEENEY, CLARENCE T.TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOOD as inventors, filed21, May, 2010, which is currently co-pending or is an application ofwhich a currently co-pending application is entitled to the benefit ofthe filing date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/800,793,titled SYSTEMS, DEVICES, AND METHODS INCLUDING INFECTION-FIGHTING ANDMONITORING SHUNTS, naming RALPH G. DACEY, JR., RODERICK A. HYDE, MURIELY. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, NATHAN P. MYHRVOLD,DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A. SWEENEY, CLARENCE T.TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOOD as inventors, filed21, May, 2010, now U.S. Pat. No. 8,414,517 or is an application of whicha currently co-pending application is entitled to the benefit of thefiling date.

For purposes of the United States Patent and Trademark Office (USPTO)extra-statutory requirements, the present application constitutes acontinuation-in-part of U.S. patent application Ser. No. 12/800,798,titled SYSTEMS, DEVICES, AND METHODS INCLUDING INFECTION-FIGHTING ANDMONITORING SHUNTS, naming RALPH G. DACEY, JR., RODERICK A. HYDE, MURIELY. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, NATHAN P. MYHRVOLD,DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A. SWEENEY, CLARENCE T.TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOOD as inventors, filed21, May, 2010, which is currently co-pending or is an application ofwhich a currently co-pending application is entitled to the benefit ofthe filing date.

For purposes of the USPTO extra-statutory requirements, the presentapplication is related to U.S. patent application Ser. No. 12/927,290,titled SYSTEMS, DEVICES, AND METHODS INCLUDING CATHETERS CONFIGURED TOMONITOR AND INHIBIT BIOFILM FORMATION, naming RALPH G. DACEY, JR.,RODERICK A. HYDE, MURIEL Y. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT,NATHAN P. MYHRVOLD, DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A.SWEENEY, CLARENCE T. TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOODas inventors, filed 10, Nov., 2010.

For purposes of the USPTO extra-statutory requirements, the presentapplication is related to U.S. patent application Ser. No. 12/927,297,titled SYSTEMS, DEVICES, AND METHODS INCLUDING CATHETERS HAVINGCOMPONENTS THAT ARE ACTIVELY CONTROLLABLE BETWEEN TRANSMISSIVE ANDREFLECTIVE STATES, naming RALPH G. DACEY, JR., RODERICK A. HYDE, MURIELY. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, NATHAN P. MYHRVOLD,DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A. SWEENEY, CLARENCE T.TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOOD as inventors, filed10, Nov., 2010.

For purposes of the USPTO extra-statutory requirements, the presentapplication is related to U.S. patent application Ser. No. 12/927,284,titled SYSTEMS, DEVICES, AND METHODS INCLUDING CATHETERS HAVINGCOMPONENTS THAT ARE ACTIVELY CONTROLLABLE BETWEEN TWO OR MOREWETTABILITY STATES, naming RALPH G. DACEY, JR., RODERICK A. HYDE, MURIELY. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, NATHAN P. MYHRVOLD,DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A. SWEENEY, CLARENCE T.TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOOD as inventors, filed10, Nov., 2010.

For purposes of the USPTO extra-statutory requirements, the presentapplication is related to U.S. patent application Ser. No. 12/927,296,titled SYSTEMS, DEVICES, AND METHODS INCLUDING CATHETERS HAVINGUV-ENERGY EMITTING COATINGS, naming RALPH G. DACEY, JR., RODERICK A.HYDE, MURIEL Y. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, NATHAN P.MYHRVOLD, DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A. SWEENEY,CLARENCE T. TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOOD asinventors, filed 10, Nov., 2010.

For purposes of the USPTO extra-statutory requirements, the presentapplication is related to U.S. patent application Ser. No. 12/927,287,titled SYSTEMS, DEVICES, AND METHODS INCLUDING CATHETERS HAVINGSELF-CLEANING SURFACES, naming RALPH G. DACEY, JR., RODERICK A. HYDE,MURIEL Y. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, NATHAN P.MYHRVOLD, DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A. SWEENEY,CLARENCE T. TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOOD asinventors, filed 10, Nov., 2010.

For purposes of the USPTO extra-statutory requirements, the presentapplication is related to U.S. patent application Ser. No. 12/927,294,titled SYSTEMS, DEVICES, AND METHODS INCLUDING CATHETERS CONFIGURED TOMONITOR BIOFILM FORMATION HAVING BIOFILM SPECTRAL INFORMATION CONFIGUREDAS A DATA STRUCTURE, naming RALPH G. DACEY, JR., RODERICK A. HYDE,MURIEL Y. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT, NATHAN P.MYHRVOLD, DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A. SWEENEY,CLARENCE T. TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOOD asinventors, filed 10, Nov., 2010.

For purposes of the USPTO extra-statutory requirements, the presentapplication is related to U.S. patent application Ser. No. 12/927,285,titled SYSTEMS, DEVICES, AND METHODS INCLUDING CATHETERS HAVINGACOUSTICALLY ACTUATABLE WAVEGUIDE COMPONENTS FOR DELIVERING ASTERILIZING STIMULUS TO A REGION PROXIMATE A SURFACE OF THE CATHETER,naming RALPH G. DACEY, JR., RODERICK A. HYDE, MURIEL Y. ISHIKAWA, JORDINT. KARE, ERIC C. LEUTHARDT, NATHAN P. MYHRVOLD, DENNIS J. RIVET, MICHAELA. SMITH, ELIZABETH A. SWEENEY, CLARENCE T. TEGREENE, LOWELL L. WOOD,JR., VICTORIA Y. H. WOOD as inventors, filed 10, Nov., 2010.

For purposes of the USPTO extra-statutory requirements, the presentapplication is related to U.S. patent application Ser. No. 12/927,291,titled SYSTEMS, DEVICES, AND METHODS INCLUDING CATHETERS HAVING LIGHTREMOVABLE COATINGS BASED ON A SENSED CONDITION, naming RALPH G. DACEY,JR., RODERICK A. HYDE, MURIEL Y. ISHIKAWA, JORDIN T. KARE, ERIC C.LEUTHARDT, NATHAN P. MYHRVOLD, DENNIS J. RIVET, MICHAEL A. SMITH,ELIZABETH A. SWEENEY, CLARENCE T. TEGREENE, LOWELL L. WOOD, JR.,VICTORIA Y. H. WOOD as inventors, filed 10, Nov., 2010.

For purposes of the USPTO extra-statutory requirements, the presentapplication is related to U.S. patent application Ser. No. 12/927,295,titled SYSTEMS, DEVICES, AND METHODS INCLUDING CATHETERS CONFIGURED TORELEASE ULTRAVIOLET ENERGY ABSORBING AGENTS, naming RALPH G. DACEY, JR.,RODERICK A. HYDE, MURIEL Y. ISHIKAWA, JORDIN T. KARE, ERIC C. LEUTHARDT,NATHAN P. MYHRVOLD, DENNIS J. RIVET, MICHAEL A. SMITH, ELIZABETH A.SWEENEY, CLARENCE T. TEGREENE, LOWELL L. WOOD, JR., VICTORIA Y. H. WOODas inventors, filed 10, Nov., 2010.

The USPTO has published a notice to the effect that the USPTO's computerprograms require that patent applicants reference both a serial numberand indicate whether an application is a continuation orcontinuation-in-part. Stephen G. Kunin, Benefit of Prior-FiledApplication, USPTO Official Gazette Mar. 18, 2003, available athttp://www.uspto.gov/web/offices/com/sol/og/2003/week11/patbene.htm. Thepresent Applicant Entity (hereinafter “Applicant”) has provided above aspecific reference to the application(s) from which priority is beingclaimed as recited by statute. Applicant understands that the statute isunambiguous in its specific reference language and does not requireeither a serial number or any characterization, such as “continuation”or “continuation-in-part,” for claiming priority to U.S. patentapplications. Notwithstanding the foregoing, Applicant understands thatthe USPTO's computer programs have certain data entry requirements, andhence Applicant is designating the present application as acontinuation-in-part of its parent applications as set forth above, butexpressly points out that such designations are not to be construed inany way as any type of commentary and/or admission as to whether or notthe present application contains any new matter in addition to thematter of its parent application(s).

All subject matter of the Related applications and of any and allparent, grandparent, great-grandparent, etc. applications of the Relatedapplications is incorporated herein by reference to the extent suchsubject matter is not inconsistent herewith.

SUMMARY

In an aspect, the present disclosure is directed to, among other things,a catheter device. In an embodiment, the catheter device includes a bodystructure having an outer surface and an inner surface defining one ormore fluid-flow passageways. In an embodiment, the catheter deviceincludes a plurality of selectively actuatable energy waveguidesoperably coupled to one or more energy emitters and configured to directelectromagnetic energy to one or more regions near or on the catheterdevice. For example, in an embodiment, selected ones of the plurality ofselectively actuatable energy waveguides are actuated to direct apatterned electromagnetic energy stimulus to one or more regionsproximate (e.g., on, near, or the like) at least one of the outersurface or the inner surface of the body structure.

In an embodiment, the plurality of selectively actuatable energywaveguides are operably coupled to one or more energy emitters via atleast one optical router. In an embodiment, the optical router isconfigured to create a translucent optical connection from the one ormore energy emitters to selective ones of the plurality of selectivelyactuatable energy waveguides. Such a connection allows electromagneticenergy to flow from the one or more energy emitters to selected ones ofthe plurality of selectively actuatable energy waveguides. In anembodiment, the optical router is actuated via one or moremechanical-optic components, electro-optic components, or acousto-opticcomponents. In an embodiment, the catheter device includes an overmodedelectromagnetic energy waveguide photonically coupled to one or more ofthe plurality of selectively actuatable energy waveguides. In anembodiment, the overmoded electromagnetic energy waveguide is configuredto actuate one or more of the plurality of selectively actuatable energywaveguides.

In an embodiment, the catheter device includes at least one reflectivesurface forming part of at least a portion of the body structure that isreflective at a first wavelength and transmissive at a second wavelengthdifferent from the first wavelength. In an embodiment, the catheterdevice includes at least one reflective surface forming part of at leasta portion of the body structure that is reflective at a firstpolarization and transmissive at a second polarization. In anembodiment, the catheter device includes at least one reflective surfaceforming part of at least a portion of the body structure that isreflective at a first power level and transmissive at a second powerlevel.

In an embodiment, the catheter device includes one or more internallyreflective components forming part of at least a portion of the bodystructure. For example, in an embodiment, the catheter device includesat least one of an outer internally reflective coating and an innerinternally reflective coating configured to internally reflect at leasta portion of an emitted energy stimulus within an interior of at leastone of the one or more fluid-flow passageways.

In an embodiment, the internally reflective components are configured tomanage a delivery of interrogation energy to a sample and configured tomanage a collection of emitted interrogation energy or remittedinterrogation energy from the sample. For example, in an embodiment, theinternally reflective components are configured to directelectromagnetic energy to a sample within at least one of the one ormore fluid-flow passageways and further configured to manage acollection of a spectral response to the interrogation energy from thesample.

In an embodiment, the catheter device includes one or more opticalmaterials forming part of at least a portion of the body structure. Inan embodiment, the one or more optical materials are configured to limitan amount of the energy stimulus that can traverse within the one ormore fluid-flow passageways and through the outer surface of the bodystructure. In an embodiment, the catheter device includes one or moreoptical materials on at least a portion of the body structure thatreflect an emitted energy stimulus within an interior of at least one ofthe one or more fluid-flow passageways. In an embodiment, the catheterdevice includes an optical component that directs at least a portion ofan emitted energy stimulus from the one or more energy emitters to oneor more of the plurality of selectively actuatable energy waveguides. Inan embodiment, the catheter device includes one or more proximalcatheters, distal catheters, or flow-regulating devices having one ormore fluid-flow passageways extending through an interior of the one ormore proximal catheters, distal catheters, or flow-regulating devices.

In an embodiment, the catheter device includes a power source having atleast one of a thermoelectric generator, a piezoelectric generator, anelectromechanical generator, or a biomechanical-energy harvestinggenerator. In an embodiment, the catheter device includes one or moresensors for detecting a microbial presence in one or more regionsproximate at least one of the outer surface of the body structure, theinner surface of the body structure, or within at least one of the oneor more fluid flow passageways. In an embodiment, the catheter deviceincludes a computing device operably coupled to at least one of theplurality of selectively actuatable energy waveguides, the one or moresensors, the power source, as well as other components of the catheterdevice. In an embodiment, the computing device actuates one or more ofthe plurality of selectively actuatable energy waveguides in response todetected information from the one or more sensors. In an embodiment, thecomputing device actuates one or more of the plurality of selectivelyactuatable energy waveguides in response to a scheduled program, anexternal command, a history of a previous microbial presence, or ahistory of a previous actuation.

In an aspect, the present disclosure is directed to, among other things,a catheter device including an energy emitter component that deliversoptical energy to one or more regions proximate the catheter device. Inan embodiment, the catheter device includes a sensor component and oneor more computer-readable memory media having biofilm marker informationconfigured as a data structure. In an embodiment, the data structureincludes a characteristic information section having characteristicmicrobial colonization spectral information representative of thepresence of a microbial colonization proximate the catheter device. Inan embodiment, the sensor component is operable to detect at least oneof an electromagnetic energy, a thermal energy, or an acoustic energyfrom one or more regions proximate the catheter device and to generate afirst response based on the detected energy. In an embodiment, thegenerated first response includes comparing detect at least one of theelectromagnetic energy, the thermal energy, or the acoustic energy tothe biofilm marker information and initiating a treatment protocol basedon the comparison. In an embodiment, the catheter device includes atleast one transmitter for sending information based at least in part ondetecting at least one of the electromagnetic energy, the thermalenergy, or the acoustic energy. In an embodiment, the catheter deviceincludes at least one transmitter configured to send a request fortransmission of at least one of data, a command, an authorization, anupdate, or a code. In an embodiment, the catheter device includescircuitry configured to obtain information and circuitry configured tostore the obtained information. In an embodiment, the catheter deviceincludes a cryptographic logic component.

In an aspect, the present disclosure is directed to, among other things,a system including a catheter device having a plurality of independentlyaddressable energy emitting components disposed along a longitudinalaxis of the catheter device. In an embodiment, the plurality ofindependently addressable energy emitting components are configured todirect an emitted energy stimulus to one or more regions proximate atleast one of the outer surface or the inner surface of the bodystructure. In an embodiment, the system further includes circuitryconfigured to determine a microorganism colonization event in one ormore regions proximate at least one of the outer surface or the innersurface of the body structure. In an embodiment, the system furtherincludes actuating means for concurrently or sequentially actuating twoor more of the plurality of independently addressable energy emittingcomponents in one or more regions determined to have a microorganismcolonization event.

In an aspect, the present disclosure is directed to, among other things,a catheter device. In an embodiment, the catheter device includes one ormore selectively actuatable energy waveguides extending over a portionof a surface of a body structure. In an embodiment, the one or moreselectively actuatable energy waveguides are configured to direct anemitted energy stimulus from one or more energy emitters to one or moreregions proximate the surface of the body structure. In an embodiment,the catheter device includes one or more sensors and one or moreswitches associated with one or more of the selectively actuatableenergy waveguides. In an embodiment, the one or more sensors areconfigured to detect a spectral property associated with the presence ofa microbial colonization in one or more regions proximate the surface ofthe body structure. For example, in an embodiment, at least one sensoris configured to detect a change to a refractive index associated withthe presence of a microbial colonization. In an embodiment, the switchesare configured to establish or interrupt a connection between theselectively actuatable energy waveguides and respective ones of the oneor more energy emitters based on the detected spectral property.

In an aspect, the present disclosure is directed to, among other things,a method of inhibiting a microbial colonization of a partially orcompletely implanted catheter device. In an embodiment, the methodincludes generating an evanescent electromagnetic field proximate one ormore regions of at least one of an outer surface or an inner surface ofa body structure of the partially or completely implanted catheterdevice based on an automatically detected spectral parameter indicativeof the presence of an infectious agent.

In an aspect, the present disclosure is directed to, among other things,a method of modulating microbial activity proximate a surface of an atleast partially implanted catheter device. In an embodiment, the methodincludes generating a spatially patterned evanescent electromagneticfield proximate one or more surface regions of the at least partiallyimplanted catheter device based on a detected change to a refractiveindex property associated with the one or more surface regions of the atleast partially implanted catheter device.

In an aspect, a method includes, among other things, selectivelyenergizing a plurality of regions proximate a surface of an implantedportion of a catheter device via one or more energy-emitting componentsin response to real-time detected information associated with abiological sample within one or more regions proximate the surface ofthe implanted portion of the catheter device. In an embodiment, themethod further includes determining a microbial colonization score inresponse to real-time detected information. In an embodiment, the methodfurther includes energetically interrogating the one or more regionsproximate the surface of the implanted portion of the catheter devicebased on the determined microbial colonization score.

In an aspect, the present disclosure is directed to, among other things,a method of inhibiting biofilm formation in a catheter device. In anembodiment, the method includes actuating one or more selectivelyactuatable energy waveguides of an at least partially implanted catheterdevice in response to an in vivo detected change in a refractive indexparameter associated with a biological sample proximate an outer surfaceor an inner surface of the catheter device.

In an aspect, the present disclosure is directed to, among other things,an at least partially implantable catheter device including a bodystructure having a plurality of actuatable regions that areindependently actuatable between at least a first transmissive state anda second transmissive state. In an embodiment, the at least partiallyimplantable catheter device includes one or more sensors for detectingat least one characteristic associated with a biological sampleproximate at least one of an outer surface or an inner surface of thebody structure. In an embodiment, the at least partially implantablecatheter device includes one or more energy emitters configured to emitan energy stimulus based at least in part on at least one detectedcharacteristic associated with the biological sample.

In an embodiment, the at least partially implantable catheter deviceincludes one or more actively controllable reflective or transmissivecomponents for outwardly transmitting or internally reflecting an energystimulus propagated therethrough. In an embodiment, the at leastpartially implantable catheter device includes one or more opticalmaterials on a portion of a body structure to internally reflect atleast a portion of an emitted energy stimulus from the one or moreenergy emitters into an interior of at least one fluid-flow passageway.

In an embodiment, the at least partially implantable catheter deviceincludes a computing device operably coupled to at least one of theplurality of actuatable regions, the actively controllable reflective ortransmissive components, or the energy emitters. In an embodiment, thecomputing device causes a change between the first and the secondtransmissive states based on detected information from the one or moresensors. For example, in an embodiment, the computing device causes achange between a transmissive state and a reflective state based ondetected information from the one or more sensors. In an embodiment, thecomputing device actuates one or more of the plurality of actuatableregions between the at least first transmissive state and the secondtransmissive state based on a comparison of a detected characteristicassociated with the biological sample proximate the body structure.

In an aspect, the present disclosure is directed to, among other things,a catheter device including a body structure having one or more surfaceregions that are configured to controllably actuate between at least afirst wettability state and a second wettability state. In anembodiment, the catheter device includes a computing device operablycoupled to the surface regions and configured to controllably actuatethe surface regions between at least a first wettability state and asecond wettability state. For example, in an embodiment, the computingdevice is configured to cause a change between a first wettability stateand a second wettability state based on detected information indicatinga presence of an infectious agent near or on the catheter device.

In an embodiment, the catheter device includes an actively controllableexcitation component configured to deliver, in vivo, an energy stimulusto one or more regions proximate at least one of the outer surface orthe inner surface of the body structure. In an embodiment, the activelycontrollable excitation component is configured to deliver, concurrentlyor sequentially, at least a first energy stimulus or a second energystimulus. In an embodiment, the first energy stimulus comprises anelectromagnetic energy stimulus, an electrical energy stimulus, anacoustic energy stimulus, or a thermal energy stimulus, and the secondenergy stimulus comprises a different one of an electromagnetic energystimulus, an electrical energy stimulus, an acoustic energy stimulus, ora thermal energy stimulus.

In an aspect, the present disclosure is directed to, among other things,a method of inhibiting biofilm formation. In an embodiment, the methodincludes actuating one or more surface regions of a catheter devicebetween at least a first wettability state and a second wettabilitystate in response to a detected event associate with a microbialcolonization proximate one or more surface regions of a catheter device.

In an aspect, the present disclosure is directed to, among other things,a catheter device including a body structure having an outer surface andan inner surface defining one or more fluid-flow passageway and one ormore actuatable energy waveguides. In an embodiment, the one or moreactuatable energy waveguides are configured to direct an emitted energystimulus to one or more regions proximate at least one of the outersurface or the inner surface of the body structure, and to deliver apatterned energy stimulus to the one or more regions proximate at leastone of the outer surface or the inner surface of the body structure. Inan embodiment, the catheter device includes an active agent assemblyincluding at least one reservoir. In an embodiment, the active agentassembly is configured to deliver one or more active agents from the atleast one reservoir to one or more regions proximate at least one of theouter surface or the inner surface of the body structure.

In an embodiment, the catheter device includes control circuitryoperably coupled to the one or more actuatable energy waveguides andconfigured to control at least one of a spaced-apart configurationparameter, an electromagnetic energy spatial distribution parameter, oran electromagnetic energy temporal distribution parameter associatedwith the delivery of the patterned energy stimulus. In an embodiment,the catheter device includes a computing device operably coupled to theone or more actuatable energy waveguides and configured to control atleast one of a delivery regiment, a spatial distribution, or a temporaldistribution associated with the delivery of the patterned energystimulus.

In an embodiment, the catheter device includes one or more sensorsconfigured to detect at least one characteristic associated one or moreregions proximate at least one of the outer surface or the inner surfaceof the body structure. In an embodiment, the catheter device includes aplurality of spaced-apart-release-ports operably coupled to at least onecomputing device. In an embodiment, the computing device is configuredto actuate one or more of the plurality of spaced-apart-release-portsbetween an active agent discharge state and an active agent retentionstate based on a comparison of a detected characteristic to storedreference data. In an embodiment, the catheter device includes at leastone receiver configured to acquire information based at least in part onwhether a detect optical energy from one or more regions proximate atleast one of the outer surface or the inner surface of the bodystructure satisfies a target condition.

In an aspect, the present disclosure is directed to, among other things,a method of inhibiting a microbial colonization of a surface on animplanted portion of a catheter device. In an embodiment, the methodincludes selectively energizing one or more regions proximate at leastone of an outer surface or an inner surface of the implanted portion ofthe catheter device via one or more energy-emitting components. In anembodiment, the method includes delivering an active agent compositionto the one or more regions proximate one or more surfaces of theimplanted portion of the catheter device, via one or more active agentassemblies, in response to an automatically detected measurandassociated with biological sample proximate the one or more surfaces ofthe implanted portion.

In an aspect, the present disclosure is directed to, among other things,an at least partially implantable fluid management system. In anembodiment, the at least partially implantable fluid management systemincludes a catheter device having a body structure having at least anouter surface and an inner surface defining one or more fluid-flowpassageways. In an embodiment, the at least partially implantable fluidmanagement system includes a plurality of independently activatableultraviolet energy delivering substrates configured to deliver asterilizing energy stimulus to one or more regions proximate at leastone of the outer surface or the inner surface of the body structure. Inan embodiment, the plurality of independently activatable ultravioletenergy delivering substrates define at least a portion of at least oneof the outer surface or the inner surface of the body structure.

In an embodiment, the at least partially implantable fluid managementsystem includes a sensor component including one or more sensorsconfigured to detect a microbial presences proximate at least one of theouter surface or the inner surface of the body structure. In anembodiment, the at least partially implantable fluid management systemincludes a computing device operably coupled to the plurality ofindependently activatable ultraviolet energy delivering substrates, andconfigured to activate one or more of the plurality of independentlyactivatable ultraviolet energy delivering substrates in response todetected microbial presence information from the sensor component.

In an aspect, a method includes, but is not limited to, concurrently orsequentially delivering to one or more regions proximate a surface of acatheter device a spatially patterned sterilizing energy stimulus via aplurality of independently activatable ultraviolet energy deliveringsubstrates. In an embodiment, the plurality of independently activatableultraviolet energy delivering substrates are configured to independentlyactivate in response to a real-time detected measurand associated with abiological sample within the one or more regions proximate the surfaceof the catheter device.

In an aspect, a method includes, but is not limited to, concurrently orsequentially delivering to one or more regions proximate a surface of acatheter device a temporally patterned sterilizing energy stimulus via aplurality of independently activatable ultraviolet energy deliveringsubstrates. In an embodiment, the plurality of independently activatableultraviolet energy delivering substrates are configured to independentlyactivate in response to a real-time detected measurand associated withat least one of temporal metabolite information or spatial metaboliteinformation associated with a biological sample within the one or moreregions proximate the surface of the catheter device.

In an aspect, the present disclosure is directed to, among other things,a catheter device having a body structure defining one or morecatheters. In an embodiment, at least a portion of the body structureincludes one or more self-cleaning surface regions. For example, in anembodiment, the catheter device includes one or more self-cleaningsurface regions having structural components or coatings that modulate(e.g., inhibit, etc.) the adherence of biofilms. In an embodiment, thecatheter device includes one or more self-cleaning surface regionsincluding a self-cleaning coating composition.

In an embodiment, the catheter device further includes one or moreselectively actuatable energy waveguides configured to direct an emittedenergy stimulus to one or more regions proximate at least one of anouter surface or an inner surface of the one or more catheters. In anembodiment, the catheter device includes one or more energy emittersoperatively coupled to the one or more selectively actuatable energywaveguides and configured to emit an energy stimulus.

In an aspect, a method includes, but is not limited to, automaticallycomparing one or more characteristics communicated from a catheterdevice to stored reference data. In an embodiment, the one or morecharacteristics include at least one of information associated with amicrobial colonization proximate the catheter device, informationassociated with an infection marker detected proximate the catheterdevice, or information associated with a sample received within one ormore fluid-flow passageways of the catheter device. In an embodiment,the method includes initiating a treatment protocol based at least inpart on the comparison.

In an embodiment, the method includes selectively energizing one or moreregions proximate the surface on an implanted portion of the catheterdevice via one or more energy-emitting components based at least in parton the comparison. In an embodiment, the method includes selectivelyenergizing one or more regions proximate the surface on an implantedportion of the catheter device via one or more selectively actuatableenergy waveguides configured to direct an emitted energy stimulus to oneor more regions proximate at least one of the outer surface or the innersurface of the body structure. In an embodiment, the method includesselectively energizing one or more regions proximate the surface on animplanted portion of the catheter device determined to have a microbialcolonization based at least in part on the comparison.

In an aspect, a method includes, but is not limited to, electronicallycomparing one or more characteristics communicated from an implantedcatheter device to stored reference data, the one or morecharacteristics including at least one of an in vivo detected microbialcolonization presence proximate a surface of the implanted catheterdevice, an in vivo real-time detected infection marker presenceproximate a surface of the implanted catheter device, and in vivodetected measurand associated with a biofilm-specific tag. In anembodiment, the method includes initiating a treatment protocol based atleast in part on the comparison.

In an aspect, the present disclosure is directed to, among other things,a catheter device. In an embodiment, the catheter device includes a bodystructure and one or more acoustically actuatable electromagnetic energywaveguides configured to direct an emitted energy stimulus to one ormore regions proximate the body structure. In an embodiment, thecatheter device includes one or more energy emitters operatively coupledto the one or more acoustically actuatable electromagnetic energywaveguides.

In an aspect, the present disclosure is directed to, among other things,a method of inhibiting biofilm formation in catheter device. In anembodiment, the method includes acoustically modulating one or moreinternally reflecting optical waveguides so as to partially emit anelectromagnetic energy propagating within the one or more internallyreflecting optical waveguides through at least one of an outer surfaceor an inner surface of the catheter device. In an embodiment, the methodincludes applying an acoustic energy stimulus to the one or moreinternally reflecting optical waveguides of a character and for asufficient duration to affect at least one of an index of refraction ora physical dimension of the one or more internally reflecting opticalwaveguides.

In an aspect, the present disclosure is directed to, among other things,a method of inhibiting biofilm formation in a catheter device. In anembodiment, the method includes selectively actuating one or moreoptical waveguides so as to partially emit an electromagnetic energypropagating within the one or more optical waveguides through at leastone of an outer surface or an inner surface of the catheter device. Inan embodiment, the method includes selectively actuating the one or moreoptical waveguides in response to real-time detected informationassociated with a microbial colonization in one or more regionsproximate at least one of an outer surface or an inner surface of thecatheter device.

In an aspect, a method includes, but is not limited to, detecting ameasurand associated with a microbial presence proximate at a surface ofa catheter device using an interrogation energy having a first peakemission wavelength. In an embodiment, the method includes delivering asterilizing stimulus having a second peak emission wavelength differentfrom the first peak emission wavelength to one or more regions proximatethe surface on the catheter device in response to the detecting ameasurand.

In an aspect, a method includes, but is not limited to, real-timemonitoring of a plurality of portions of a catheter device for amicrobial colonization by detecting spectral information associated withan interrogating stimulus having a first peak emission wavelength. In anembodiment, the method includes delivering a sterilizing stimulus havinga second peak emission wavelength different from the first peak emissionwavelength to select ones of the plurality of portions of the catheterdevice based on a determined microbial colonization score.

In an aspect, a method includes, but is not limited to, real-timemonitoring at least one of an outer surface or an inner surface of anindwelling portion of a catheter device for a microbial colonization bydetecting spectral information associated with an interrogating stimulushaving a first peak emission wavelength. In an embodiment, the methodincludes delivering an interrogating stimulus to one or more regionproximate the at least one of the outer surface or the inner surface ofan indwelling portion of a catheter device.

In an embodiment, the method includes determining a microbialcolonization score for the one or more region proximate one or moresurfaces of an indwelling portion of a catheter device in response todetecting spectral information. In an embodiment, the method includesselective-delivering a sterilizing stimulus having a second peakemission wavelength different from the first peak emission wavelength toat least one of the one or more region proximate one or more surfaces ofan indwelling portion of a catheter device based on a determinedmicrobial colonization score.

In an aspect, the present disclosure is directed to, among other things,an implantable catheter device including a plurality of regions havingone or more in vivo selectively removable protective coatings definingat least a portion of at least one of the outer surface or the innersurface of the body structure. In an embodiment, the body structureincludes an outer surface or an inner surface defining one or morefluid-flow passageways and is configured to transmit at least a portionof an emitted energy stimulus propagated within the body structurethough one or more of a the plurality of regions having had an in vivoselectively removable protective coating removed. In an embodiment, theimplantable catheter device includes circuitry configured to determine amicroorganism colonization event in one or more of the plurality ofregions having the one or more in vivo selectively removable protectivecoatings.

In an aspect, the present disclosure is directed to, among other things,a catheter device including a body structure a plurality of selectivelyactuatable waveguides elements defining at least a portion of a surfaceof the body structure. In an embodiment, the selectively actuatablewaveguides elements are configured to guide an emitted ultravioletenergy stimulus to one or more regions proximate the surface of the bodystructure. In an embodiment, the catheter device includes an activeagent assembly including at least one reservoir, the active agentassembly configured to deliver an ultraviolet energy absorbing agentfrom the at least one ultraviolet energy absorbing reservoir to one ormore regions proximate the surface of the body structure. In anembodiment, one or more of the plurality of selectively actuatablewaveguides elements are configured to guide one or more of anelectromagnetic energy stimulus, an acoustic energy stimulus, anacoustic energy stimulus, and a thermal energy stimulus.

In an aspect, a method includes, but is not limited to, delivering anultraviolet energy absorbing composition to one or more regionsproximate a surface of a catheter device prior to delivering a patternedenergy stimulus to the one or more regions based on a detected measurandassociated with biological sample proximate the one or more regions.

In an aspect, a method includes, but is not limited to, delivering anultraviolet energy absorbing composition to one or more regionsproximate an implanted portion of a catheter device prior to selectivelyenergizing the one or more regions in response to a real-time detectedspectral information associated with a microbial presence within the oneor more regions. In an embodiment, the method includes delivering asterilizing stimulus to select ones of the one or more regions inresponse to the real-time detected spectral information associated withthe microbial presence within the one or more regions.

The foregoing summary is illustrative only and is not intended to be inany way limiting. In addition to the illustrative aspects, embodiments,and features described above, further aspects, embodiments, and featureswill become apparent by reference to the drawings and the followingdetailed description.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1A is a perspective view of a system including a catheter deviceaccording to one embodiment.

FIG. 1B is a perspective view of a portion of catheter device includinga fluid-flow passageway according to one embodiment.

FIG. 2 is a perspective view of a system including a catheter deviceaccording to one embodiment.

FIG. 3 is a schematic diagram of a system including a catheter deviceaccording to one embodiment.

FIG. 4 is a top plan view of a portion of a catheter device includingplurality of selectively actuatable energy waveguides configured toprovide a patterned energy stimulus, according to one embodiment.

FIG. 5 is a schematic diagram of a system including a catheter deviceaccording to one embodiment.

FIG. 6 is a schematic diagram of a system including a catheter deviceaccording to one embodiment.

FIG. 7 is a schematic diagram of a system including a catheter deviceaccording to one embodiment.

FIG. 8 is a schematic diagram of a system including a catheter deviceaccording to one embodiment.

FIG. 9 is a schematic diagram of a system including a catheter deviceaccording to one embodiment.

FIG. 10A is a flow diagram of a method according to one embodiment.

FIG. 10B is a flow diagram of a method according to one embodiment.

FIG. 11 is a flow diagram of a method according to one embodiment.

FIGS. 12A, 12B, and 12C are flow diagrams of a method according to oneembodiment.

FIG. 13 is a flow diagram of a method according to one embodiment.

FIG. 14 is a flow diagram of a method according to one embodiment.

FIGS. 15A and 15B are flow diagrams of a method according to oneembodiment.

FIG. 16 is a flow diagram of a method according to one embodiment.

FIG. 17 is a flow diagram of a method according to one embodiment.

FIGS. 18A and 18B are flow diagrams of a method according to oneembodiment.

FIG. 19 is a flow diagram of a method according to one embodiment.

FIG. 20 is a flow diagram of a method according to one embodiment.

FIG. 21 is a flow diagram of a method according to one embodiment.

FIG. 22 is a flow diagram of a method according to one embodiment.

FIG. 23 is a flow diagram of a method according to one embodiment.

FIG. 24 is a flow diagram of a method according to one embodiment.

FIG. 25 is a flow diagram of a method according to one embodiment.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrative embodiments described in thedetailed description, drawings, and claims are not meant to be limiting.Other embodiments can be utilized, and other changes can be made,without departing from the spirit or scope of the subject matterpresented here.

Catheters (e.g., central venous catheters, multi-lumen catheters,peripherally inserted central catheters, Quinton catheters, Swan-Ganzcatheters, tunneled catheters, intravenous lines, or the like), shunts(e.g., cardiac shunts, cerebral shunts, portacaval shunts, portosystemicshunts, pulmonary shunts, or the like), medical ports (e.g., arterialports, low profile ports, multi-lumen ports, vascular ports, or thelike), or the like are useful for, among other things, managing movementof fluids; directly detecting (e.g., assessing, calculating, evaluating,determining, gauging, identifying, measuring, monitoring, quantifying,resolving, sensing, or the like) mechanical, physical, or biochemicalinformation (e.g., the presence of a biomarker, intracranial pressure,blood pressure, a disease state, or the like) associated with abiological subject; draining or collecting body fluids; providing accessto surgical tools; as well as for administering therapeutics,medications, pharmaceuticals, intravenous fluids, blood products, orparenteral nutrition.

Infections, malfunctions (e.g., blocked or clogged fluid-flowpassageways, etc.), and failures account for many of the complicationsassociated with implantable medical devices (e.g., catheter devices,etc.) and pose tremendous consequences for patients. For example, duringan infection, an infectious agent (e.g., fungi, microorganisms,parasites, pathogens (e.g., viral pathogens, bacterial pathogens, or thelike), prions, viroids, viruses, or the like) generally interferes withthe normal functioning of a biological subject, and causes, in somecases, chronic wounds, necrosis, loss of an infected tissue, loss of aninfected limb, and occasionally death of the biological subject.Implant-associated infections account for a significant amount ofnosocomial infections and despite sterilization and aseptic procedures,remain as a major impediment to medical implants including artificialhearts, artificial joints, artificial prosthetics, breast implants,catheters, contact lens, implantable biological sample drainage system,mechanical heart valves, stents, subcutaneous sensors, shunts, vertebralspacers, or the like. Implant-associated infections are often difficultto detect, problematic to cure, and at times expensive to manage. Forexample, in cases where the infection fails to subside quickly, itsometimes becomes necessary to remove the implant.

Implant-associated infections can result from bacterial adhesion andsubsequent biofilm formation proximate an implantation site. Forexample, biofilm-forming microorganisms sometimes colonize the surfaceof a catheter device. Once a biofilm-induced infection takes hold, itcan prove difficult to treat. In the case of catheters, for example,infectious agents can make their way from an insertion site into anouter surface of an indwelling portion of a catheter device. Likewise,contamination of an outer portion, such as a venous line of catheterdevice, can initiate migration of an infectious agent along an internalpassageway. Adherence of infections agents to host proteins, such asfibronectin, commonly found on catheter components at times worsens theproblem. See e.g., Frasca et al., Critical Care 14:212 1-8 (2010).

Accordingly, an aspect includes systems, devices, and methods, includinga catheter device configured to, for example, detect (e.g., assess,calculate, evaluate, determine, gauge, identify, measure, monitor,quantify, resolve, sense, or the like) an infectious agent presentproximate the catheter device. A non-limiting example includes systems,devices, and methods including a catheter device configured to, forexample, detect an infectious agent present in, for example, abiological specimen (e.g., tissue, biological fluid, target sample,infectious agent, or the like) proximate (e.g., on, near, or the like) asurface of the catheter device.

An aspect includes systems, devices, methods, and compositions foractively detecting, treating, or preventing an infection associated withan indwelling catheter. An aspect includes systems, devices, and methodsfor managing movement of fluids; directly detecting and monitoringfunctions or conditions (e.g., mechanical, physical, physiological, orbiochemical functions or conditions) associated with a biologicalsubject; draining or collecting body fluids; providing access to aninterior of a biological subject; distending at least one passageway; aswell as for administering therapeutics, medications, pharmaceuticals,intravenous fluids, or parenteral nutrition. A non-limiting exampleincludes systems, devices, and methods for actively detecting, treating,or preventing fluid-flow obstructions in catheters.

FIGS. 1A and 1B show a system 100 (e.g., a catheter system, animplantable catheter system, an implantable system, an indwellingsystem, a partially implantable system, a fluid management system, orthe like) in which one or more methodologies or technologies can beimplemented such as, for example, managing a transport of fluids,providing surgical access, as well as actively detecting, treating, orpreventing an infection (e.g., an implant-associated infection, ahematogenous associated infection, an infection present in tissue orbiological fluid, a biofilm formation, a microbial colonization, or thelike), a biological sample abnormality (e.g., a cerebral spinal fluidabnormality, a hematological abnormality, a tissue abnormality, or thelike), or the like.

In an embodiment, the system 100 is configured to, among other things,reduce an in vivo concentration of an infectious agent present in abiological fluid (e.g., bodily fluid, blood, amniotic fluid, ascites,bile, cerebrospinal fluid, interstitial fluid, pleural fluid,transcellular fluid, or the like) managed by the system 100, or abiological sample proximate one or more components of the system 100. Inan embodiment, the system 100 is configured to provide antimicrobialtherapy.

In an embodiment, the system 100 includes, among other things, at leastone catheter device 102. In an embodiment, the catheter device 102includes, among other things, a body structure 104 having an outersurface 106 and an inner surface 108 defining one or more fluid-flowpassageways 110. In an embodiment, the system 100 is configured toreduce the concentration of an infectious agent in the immediatevicinity of a catheter device 102. For example, in an embodiment, thesystem 100 is configured to controllably deliver one or more energystimuli to at least one of an interior or an exterior of one or morefluid-flow passageways 110 of a catheter device 102 at a dose sufficientto modulate the activity of the infectious agent in the immediatevicinity of a catheter device.

In an embodiment, the catheter device 102 includes, among other things,one or more catheters 112. In an embodiment, the catheter device 102 ispositioned to facilitate the administration of therapeutics,medications, pharmaceuticals, intravenous fluids, blood products,parenteral nutrition, or the like. In an embodiment, the catheter device102 is positioned to provide access for surgical instruments. In anembodiment, the catheter device 102 is positioned to provide vascularaccess. In an embodiment, the catheter device 102 is positioned tofacilitate drainage.

Among catheters 112, examples include, but are not limited to, arterialcatheters, dialysis catheters, drainage catheters, indwelling catheters,long term non-tunneled central venous catheters, long term tunneledcentral venous catheters, mechanical catheters, peripheral venouscatheters, peripherally insertable central venous catheters, peritonealcatheters, pulmonary artery Swan-Ganz catheters, short-term centralvenous catheters, urinary catheters, ventricular catheters, or the like.In an embodiment, the body structure 104 includes one or more catheters112 each having a proximal portion 114, a distal portion 116, and atleast one inner fluid-flow passageway 110 extending therethrough. In anembodiment, one or more of the catheters 112 are configured forinsertion into a body cavity, a duct, a vessel, or the like of a subjectin need thereof.

In an embodiment, the catheter device 102 includes one or more catheters112 configured for directly detecting and monitoring mechanical,physical, or biochemical functions associated with a biological subject;draining or collecting body fluids; providing access to an interior of abiological subject; or distending at least one passageway 110; as wellas for administering therapeutics, medications, pharmaceuticals,intravenous fluids, or nutrition. In an embodiment, the catheter device102 includes one or more at least partially implantable catheters 112.In an embodiment, the catheter device 102 includes one or more ports 118configured to provide access to, or from, an interior environment of atleast one of the one or more fluid-flow passageways 110. In anembodiment, the catheter device 102 includes one or more biocompatiblematerials, polymeric materials, thermoplastics, silicone materials(e.g., polydimethysiloxanes), polyvinyl chloride materials, latex rubbermaterials, or the like.

Further non-limiting examples of catheters 112, shunts, or componentsthereof, may be found in, for example the following documents (each ofwhich is incorporated herein by reference): U.S. Pat. No. 7,524,298(issued Apr. 28, 2009), U.S. Pat. No. 7,390,310 (issued Jun. 24, 2008),U.S. Pat. No. 7,334,594 (issued Feb. 26, 2008), U.S. Pat. No. 7,309,330(issued Dec. 18, 2007), U.S. Pat. No. 7,226,441 (issued Jun. 5, 2007),U.S. Pat. No. 7,118,548 (issued Oct. 10, 2006), U.S. Pat. No. 6,932,787(issued Aug. 23, 2005), U.S. Pat. No. 6,913,589 (issued Jul. 5, 2005),U.S. Pat. No. 6,743,190 (issued Jun. 1, 2004), U.S. Pat. No. 6,585,677(issued Jul. 1, 2003); and U.S. Patent Publication Nos. 2009/0118661(published May 7, 2009), 2009/0054824 (published Feb. 26, 2009),2009/0054827 (published Feb. 26, 2009), 2008/0039768 (published Feb. 14,2008), and 2006/0004317 (published Jan. 5, 2006); each of which isincorporated herein by reference).

FIG. 2 shows various configurations of a system 100 in which one or moremethodologies or technologies can be implemented. In an embodiment, thesystem 100 includes, among other things, at least one catheter device102 including one or more energy waveguides 202. The energy waveguides202 can take a variety of shapes, configurations, and geometriesincluding, but not limited to, cylindrical, conical, planar, parabolic,regular or irregular forms. In an embodiment, multiple energy waveguides202 are formed from a single substrate or structure. Non-limitingexamples of energy waveguides 202 include electromagnetic waveguides204, acoustic energy waveguides 206 (e.g., ultrasonic energywaveguides), thermal energy waveguides 208, optical energy waveguides210 (e.g., optical fibers, photonic-crystal fibers, or the like),ultrasound energy waveguides 212, multi-energy waveguides 214, or thelike. Further non-limiting examples of energy waveguides 202 includelens structures, light-diffusing structures, mirror structures, mirroredsurfaces, reflective coatings, reflective materials, reflectivesurfaces, or combinations thereof. Further non-limiting examples ofenergy waveguides 202 include etchings, facets, grooves, thin-films,optical micro-prisms, lenses (e.g., micro-lenses, or the like),diffusing elements, diffractive elements (e.g., gratings,cross-gratings, or the like), texturing, or the like. In an embodiment,the energy waveguides 202 include structures suitable for directingenergy waves.

In an embodiment, one or more of the energy waveguides 202 include atleast one of a transparent, translucent, or light-transmitting material,and combinations or composites thereof. Among transparent, translucent,or light-transmitting materials, examples include those materials thatoffer a low optical attenuation rate to the transmission or propagationof light waves. Non-limiting examples of transparent, translucent, orlight-transmitting materials include crystals, epoxies, glasses,borosilicate glasses, optically clear materials, semi-clear materials,plastics, thermo plastics, polymers, resins, thermal resins, or thelike, or combinations or composites thereof.

In an embodiment, the system 100 includes, among other things, aplurality of selectively actuatable energy waveguides 202 a. Forexample, in an embodiment, the catheter device 102 includes a pluralityof selectively actuatable energy waveguides 202 a that define one ormore portions of the body structure 104. In an embodiment, at least aportion of the outer surface of the body structure 104 includes one ormore of the plurality of selectively actuatable energy waveguides 202 a.In an embodiment, at least a portion of the inner surface of the bodystructure 104 includes one or more of the plurality of selectivelyactuatable energy waveguides 202 a.

Referring to FIG. 3, in an embodiment, the system 100 includes, amongother things, a catheter device 102 having body structure 104 configuredto sufficiently internally reflect at least a portion of an emittedenergy stimulus 302 and to generate an evanescent field 304 across oneor more regions of the body structure 104. In an embodiment, at least aportion of the body structure 104 includes one or more energy waveguides202 configured to sufficiently internally reflect at least a portion ofan emitted energy stimulus 302 and to generate an evanescent field 304.

Evanescent fields 304 can be generated, for example, via diffractionfrom a grating or a collection of apertures; scattering from anaperture; or total internal reflection at the interface between twomedia See e.g., Smith et. al, Evanescent Wave Imaging in OpticalLithography, Proc. SPIE 6154, (2006). For example, electromagneticenergy 302 crossing a boundary 306 between materials with differentrefractive indices (n_(i)), partially refracts at the boundary surface,and partially reflects. (See, e.g., FIG. 3). When the incident angle(θ_(i)), exceeds the critical angle of incidence, define as:

${\theta_{critical} = {\sin^{- 1}( \frac{n_{low}}{n_{high}} )}},$the electromagnetic energy traveling from a medium of higher refractiveindex (n_(high)) to that of a lower one (n_(low)) undergoes totalinternal reflection (see e.g., FIG. 3), and generates an evanescentfield 304 near the boundary 306 (the intensity of which decaysexponentially with increasing distance from the surface). In anembodiment, at least a portion of the body structure 104 is configuredto sufficiently internally reflect at least a portion of an emittedenergy stimulus 302 to cause an evanescent electromagnetic field 304 toemanate from at least a portion of the body structure 104. In anembodiment, at least a portion of the body structure 104 is configuredto internally reflect at least a portion of an emitted energy stimulus302 within an interior of at least one of the one or more fluid-flowpassageways 110. In an embodiment, at least a portion of the bodystructure 104 is configured to totally internally reflect at least aportion of an emitted energy stimulus 302 propagated within an interiorof at least one of the one or more fluid-flow passageways.

In an embodiment, infectious agents 308 cause changes in the local indexof refraction, resulting in changes in the resonance conditions of theevanescent electromagnetic field 304. In an embodiment, detected indexof refraction changes are correlated to the presence of an infectiousagent.

With continued reference to FIG. 2, in an embodiment, one or more of theenergy waveguides 202 include at least one of an optically transparent,optically translucent, or light-transmitting component. In anembodiment, one or more of the energy waveguides 202 include at leastone optically transparent, translucent, or light-transmitting material.Non-limiting examples of optically transparent, translucent, orlight-transmitting material include one or more of acetal copolymers,acrylic, glass, AgBr, AgCl, Al₂O₃, GeAsSe glass, BaF₂, CaF₂, CdTe,AsSeTe glass, CsI, diamond, GaAs, Ge, ITRAN materials, KBr, thalliumbromide-Iodide, LiF, MgF₂, NaCl, polyethylene, Pyrex, Si, SiO₂, ZnS,ZnSe, thermoplastic polymers, or thermoset polymers, and compositesthereof. Further non-limiting examples of optically transparent,translucent, or light-transmitting material include one or more ofacrylonitrile butadaine styrene polymers, cellulosic, epoxy, ethylenebutyl acrylate, ethylene tetrafluoroethylene, ethylene vinyl alcohol,fluorinated ethylene propylene, furan, nylon, phenolic,poly[2,2,4-trifluoro-5-trifluoromethoxy-1,3-dioxole-co-tetrafluoroethylene],poly[2,2-bistrifluoromethyl-4,5-difluoro-1,3-dioxole-co-tetrafluoroethylene],poly[2,3-(perfluoroalkenyl)perfluorotetrahydrofuran], polyacrylonitrilebutadiene styrene, polybenzimidazole, polycarbonate, polyester,polyetheretherketone, polyetherimide, polyethersulfone, polyethylene,polyimide, polymethyl methacrylate, polynorbornene,polyperfluoroalkoxyethylene, polystyrene, polysulfone, polyurethane,polyvinyl chloride, polyvinylidene fluoride, diallyl phthalate,thermoplastic elastomer, transparent polymers, an vinyl ester, andcomposites thereof.

In an embodiment, a plurality of energy waveguides 202 are coupled(e.g., optically coupled, operably coupled, physically coupled, or thelike) to form, for example, an array of energy waveguides 202. In anembodiment, one or more of the plurality of energy waveguides 202comprise a laminate including one or more optically active coatings,materials, or the like. In an embodiment, one or more of the pluralityof energy waveguides 202 direct an emitted energy stimulus to one ormore regions proximate at least one of the outer surface 106 or theinner surface 108 of the body structure 104. In an embodiment, theplurality of energy waveguides 202 are arranged to form a part ofpatterned energy emitting component 216.

In an embodiment, the system 100 includes, among other things, aplurality of selectively actuatable energy waveguides 202 a. In anembodiment, the catheter device 102 includes a plurality of selectivelyactuatable energy waveguides 202 a. In an embodiment, the pluralityselectively actuatable energy waveguides 202 a direct an emitted energystimulus to one or more regions proximate at least one of the outersurface 106 or the inner surface 108 of the body structure 104.

In an embodiment, the system 100 is configured to, among other things,treat a condition associated with an infection. For example, in anembodiment, upon an indication of a presence or severity of aninfection, selected ones of the plurality selectively actuatable energywaveguides 202 a are actuated to deliver an emitted energy stimulus tomodulate microbial activity within those regions having an indication ofa presence or severity of an infection. In an embodiment, the system 100is configured to, among other things, reduce the risk of infection. Inan embodiment, the system 100 is configured to, among other things,modulate a microbial colonization.

In an embodiment, the plurality of selectively actuatable energywaveguides 202 a include one or more acoustic energy waveguides 206(e.g., one or more ultrasound-guiding waveguides, or the like). In anembodiment, the plurality of selectively actuatable energy waveguides202 a include one or more thermal energy waveguides 208. In anembodiment, the plurality of selectively actuatable energy waveguides202 a include one or more electrical energy waveguides.

In an embodiment, the plurality of selectively actuatable energywaveguides 202 a include a light-transmitting material. In anembodiment, at least one of the plurality of selectively actuatableenergy waveguides 202 a includes an electromagnetic energy transmittingmaterial and a reflective boundary. In an embodiment, at least one ofthe plurality of selectively actuatable energy waveguides 202 a includesan electrical conducting portion and an electrical insulating portion.In an embodiment, at least one of the plurality of selectivelyactuatable energy waveguides 202 a includes a thermal conducting portionand a thermal insulating portion.

In an embodiment, the plurality of selectively actuatable energywaveguides 202 a include one or more optical waveguides. In anembodiment, the selectively actuatable energy waveguides 202 a includeone or more optical waveguides having one or more ports configured toallow electromagnetic energy to escape. In an embodiment, the pluralityof selectively actuatable energy waveguides 202 a include one or moreoptical waveguides having distributed light escape along a portion of alength of the one or more optical waveguides. In an embodiment, theplurality of selectively actuatable energy waveguides 202 a include oneor more optical fibers. In an embodiment, one or more of the pluralityof selectively actuatable energy waveguides 202 a comprise an opticallytransparent material and an optically opaque material.

In an embodiment, one or more of the plurality of selectively actuatableenergy waveguides 202 a are disposed along the outer surface of the bodystructure, the inner surface 108 of the body structure 104, or both. Forexample, in an embodiment, one or more of the plurality of selectivelyactuatable energy waveguides 202 a form part of the outer surface 106,to form part of the inner surface 108, or both.

In an embodiment, the system 100 includes, among other things, at leastone catheter device 102 including one or more acoustically actuatableelectromagnetic energy waveguides. In an embodiment, the one or moreacoustically actuatable electromagnetic energy waveguides direct anemitted energy stimulus to one or more regions proximate at least one ofan outer surface 106 or an inner surface 108 of the body structure 104.

In an embodiment, the one or more acoustically actuatableelectromagnetic energy waveguides include at least one of anacoustically sensitive cladding material; an acoustically sensitivematerial coating; or an acoustically deforming material coating. In anembodiment, the one or more acoustically actuatable electromagneticenergy waveguides are configured for selective-actuation via one or moretransducers. In an embodiment, the one or more acoustically actuatableelectromagnetic energy waveguides are configured to outwardly transmit aportion of an electromagnetic energy internally reflected within in thepresence of an acoustic stimulus. In an embodiment, the one or moreacoustically actuatable electromagnetic energy waveguides are configuredto deform in the presence of an acoustic stimulus. In an embodiment, theone or more acoustically actuatable electromagnetic energy waveguidesare configured to exhibit a change to a refractive index in the presenceof an acoustic stimulus. In an embodiment, the one or more acousticallyactuatable electromagnetic energy waveguides are configured to generatean evanescent electromagnetic field across one or more regions of thebody structure in the presence of an acoustic stimulus. In anembodiment, the one or more acoustically actuatable electromagneticenergy waveguides are operably coupled to one or more acoustic energyemitters.

Referring to FIG. 4, in an embodiment, the plurality of selectivelyactuatable energy waveguides 202 a provide a spatially patterned energystimulus 402. In an embodiment, the plurality of selectively actuatableenergy waveguides 202 a deliver an energy stimulus of a dose sufficient(e.g., of character and for a duration sufficient, of sufficientstrength or duration, etc.) to provide a spatially patterned energystimulus to one or more regions proximate at least a first surface 404of the body structure 104.

In an embodiment, the plurality of selectively actuatable energywaveguides 202 a provide a spatially patterned energy stimulus having atleast a first region 406 and a second region 408 different from thefirst region 406. For example, in an embodiment, the second region 408includes at least one of a spectral power distribution (SPD_(n)), anirradiance (I_(n)), or a peak power (P_(n)) different from the firstregion 406. In an embodiment, the second region 408 includes at leastone of an illumination intensity, a peak emission wavelength, or a pulsefrequency different from the first region 406. In an embodiment, thesecond region 408 includes at least one of an intensity, a phase, or apolarization different from the first region 406. In an embodiment, thesecond region 408 includes at least one of a frequency, a repetitionrate, or a bandwidth different from the first region 406. In anembodiment, the second region 408 includes at least one of anenergy-emitting pattern, an ON-pulse duration, or an OFF-pulse durationdifferent from the first region 406. In an embodiment, the second region408 includes at least one of an emission intensity, an emission phase,an emission polarization, or an emission wavelength different from thefirst region 406.

In an embodiment, the plurality of selectively actuatable energywaveguides 202 a include at least a first waveguide and a secondwaveguide, the second waveguide configured to transport electromagneticenergy of a wavelength different from that of the first waveguide. Forexample, in an embodiment, the first waveguide provides anelectromagnetic energy stimulus, an electrical energy stimulus, anacoustic energy stimulus, or a thermal energy stimulus, and the secondwaveguide provides a different one of an electromagnetic energystimulus, an electrical energy stimulus, an acoustic energy stimulus, ora thermal energy stimulus. In an embodiment, the plurality ofselectively actuatable energy waveguides 202 a are configured to deliverat least one of a spatially collimated energy stimulus; spatiallyfocused energy stimulus; a temporally patterned energy stimulus; or aspaced-apart patterned energy stimulus.

In an embodiment, the plurality of selectively actuatable energywaveguides 202 a provide an illumination pattern comprising at least afirst actuated selectively actuatable energy waveguide and a secondactuated selectively actuatable energy waveguide. In an embodiment, theplurality of selectively actuatable energy waveguides 202 a provide anillumination pattern comprising selectively actuatable energy waveguides202 a configured to be concurrently actuated.

In an embodiment, one or more energy emitter 220 are operably coupled toa plurality of selectively actuatable energy waveguides 202 a and areconfigured to deliver a multiplex energy stimulus having, for example,two or more peak emission wavelengths. In an embodiment, a multiplexenergy stimulus can be routed to two or more of the selectivelyactuatable energy waveguides 202 a based on a wavelength, an intensity,a spectral power distribution, a waveguide-specific address, or thelike. Once routed, the a plurality of selectively actuatable energywaveguides 202 a can deliver a spatially patterned energy stimulushaving at least a first region and a second region 408 different fromthe first region 406 where the difference depends on the selection rule(e.g., spectral power distribution, irradiance, peak power, intensity,phase, polarization, frequency, repetition rate, bandwidth,waveguide-specific address, or the like) used to route the energystimulus.

Referring to FIG. 2, in an embodiment, the plurality of selectivelyactuatable energy waveguides 202 a are configured to internally directat least a portion of an emitted energy stimulus propagated within aninterior of at least one of the one or more fluid-flow passageways 110.In an embodiment, the plurality of selectively actuatable energywaveguides 202 a are configured to direct at least a portion of anemitted energy stimulus within an interior of at least one of the one ormore fluid-flow passageways 110 based on at least one of a polarization,an intensity, or a wavelength. For example, in an embodiment, theplurality of selectively actuatable energy waveguides 202 a include oneor more polarization-, intensity-, or wavelength-selective elements,coatings, materials, etchings, facets, grooves, thin-films, opticalmicro-prisms, lenses (e.g., micro-lenses, or the like), diffusingelements, diffractive elements (e.g., gratings, cross-gratings, or thelike), texturing, or the like configured to direct at least a portion ofan emitted energy stimulus.

In an embodiment, the plurality of selectively actuatable energywaveguides 202 a are configured to direct at least a portion of anemitted energy stimulus within an interior of at least one of the one ormore fluid-flow passageways 110 based on a power level of the emittedenergy stimulus. In an embodiment, one or more of the plurality ofselectively actuatable energy waveguides 202 a extend over a portion ofa surface of the body structure 104.

In an embodiment, the catheter device 102 includes at least oneselectively actuatable energy waveguide 202 a that forms part of asurface along a longitudinal direction 120 of a fluid-flow passageway110. In an embodiment, the catheter device 102 includes at least oneselectively actuatable energy waveguide 202 a that forms part of asurface along a lateral direction 122 of a fluid-flow passageway 110. Inan embodiment, the plurality of selectively actuatable energy waveguides202 a are configured to laterally internally direct or longitudinallyinternally direct at least a portion of an emitted energy stimuluswithin an interior of at least one of the one or more fluid-flowpassageways 110. For example, in an embodiment, a catheter device 102includes one or more selectively actuatable energy waveguides 202 a thatextend along a longitudinal direction of a fluid-flow passageway 110.Accordingly, when actuated, the one or more selectively actuatableenergy waveguides 202 a direct at least a portion of an emitted energystimulus within an interior of at least one of the one or morefluid-flow passageways 110 along a longitudinal direction.

In an embodiment, one or more of the plurality of selectively actuatableenergy waveguides 202 a extend substantially longitudinally along atleast one of the one or more fluid-flow passageways 110. In anembodiment, one or more of the plurality of selectively actuatableenergy waveguides 202 a extend substantially laterally within at leastone of the one or more fluid-flow passageways 110. In an embodiment, atleast one of the plurality of selectively actuatable energy waveguides202 a extends substantially laterally along a first portion of the bodystructure 104 and a different one of the plurality of selectivelyactuatable energy waveguides 202 a extends substantially laterally alonga second portion of the body structure 104. In an embodiment, one ormore of the plurality of selectively actuatable energy waveguides 202 aextend substantially helically within at least one of the one or morefluid-flow passageways 110. In an embodiment, at least one of theplurality of selectively actuatable energy waveguides 202 a extendssubstantially helically along a first portion of the body structure 104and a different one of the plurality of selectively actuatable energywaveguides 202 a extends substantially helically along a second portionof the body structure 104.

In an embodiment, the plurality of selectively actuatable energywaveguides 202 a are configured to direct a first portion of an emittedenergy stimulus along a substantially lateral direction in one or moreregions of at least one of the one or more fluid-flow passageways 110and configured to direct a second portion of the emitted energy stimulusalong a substantially longitudinal direction in one or more regions ofat least one of the one or more fluid-flow passageways 110. In anembodiment, the plurality of selectively actuatable energy waveguides202 a are configured to direct at least a portion of an emitted energystimulus along a substantially lateral direction in a first region of atleast one of the one or more fluid-flow passageways 110 and configuredto direct at least a portion of the emitted energy stimulus along asubstantially lateral direction in a second region of the one or morefluid-flow passageways 110, the second region different from the firstregion. In an embodiment, the plurality of selectively actuatable energywaveguides 202 a are configured to direct at least a portion of anemitted energy stimulus along a substantially longitudinal direction ina first region of at least one of the one or more fluid-flow passageways110 and configured to direct at least a portion of the emitted energystimulus along a substantially longitudinal direction in a second regionof the one or more fluid-flow passageways 110, the second regiondifferent from the first region. In an embodiment, the plurality ofselectively actuatable energy waveguides 202 a are configured toexternally direct at least a portion of an emitted energy stimuluspropagated within. In an embodiment, the plurality of selectivelyactuatable energy waveguides 202 a are configured to externally directat least a portion of an emitted energy stimulus propagated within oneor more regions proximate at least one surface of the body structure104.

In an embodiment, the catheter device 102 includes a plurality ofselectively actuatable energy waveguides 202 a configured to selectivelyactuate via one or more switches 218. In an embodiment, the plurality ofselectively actuatable energy waveguides 202 a are selectivelyactuatable via one or more opto-mechanical switches; electro-opticswitches; acousto-optic switches; thermo-optic switches, or the like. Inan embodiment, the plurality of selectively actuatable energy waveguides202 a can be actuated via one or more thermally actuated devices (e.g.,thermally activatable switches, or the like), electromagneticallyactuated devices (e.g., electromagnetic activatable switches, opticallyactivatable switches, or the like), acoustically actuated devices,electrically actuated devices, or the like.

Non-limiting examples of switches 218, or components thereof, may befound in, for example the following documents: U.S. Patent PublicationNo. 2009/0316195 (published Dec. 24, 2009); U.S. Pat. No. 7,706,178(issued Apr. 27, 2010), U.S. Pat. No. 7,130,459 (issued Dec. 18, 2007),U.S. Pat. No. 6,853,765 (issued Feb. 8, 2005), and U.S. Pat. No.6,222,953 (issued Apr. 24, 2001); Coppola, G. et al., Visualization ofOptical Deflection and Switching Operations by a Domain-Engineered BasedLiNbO ₃ Electro-Optic Device, Optics Express, 11 (10), 1212-1222, (May2003); Liou, J. C. et al., An ASIC Control Circuit for Thermal ActuatedLarge Optical Packet Switch Array, Proceedings of the World Congress onEngineering 2008, Vol. I, WCE 2008, pp 386-391 (2008); and Yang, J., etal., Polyimide-Waveguide-Based Thermal Optical Switch UsingTotal-Internal-Reflection Effect, Applied Physics Letters, 81 (16):2947-2949 (2002); each of which is incorporated herein by reference.

In an embodiment, the catheter device 102 includes, among other things,a plurality of selectively actuatable energy waveguides 202 a configuredto selectively actuate via one or more antifuses 219. In an embodiment,the one or more antifuses 219 are operably coupled to at least one ofthe plurality of selectively actuatable energy waveguides 202 a and areconfigured to establish an electromagnetic energy path when anelectromagnetic energy transmitted therethrough exceeds a thresholdvalue.

In an embodiment, the plurality of selectively actuatable energywaveguides 202 a are selectively actuatable via one or more opticalantifuses 219. In an embodiment, the plurality of selectively actuatableenergy waveguides 202 a are selectively actuatable via one or moreantifuses 219 that are configured to actuate from a first transmissivestate to a second transmissive state when a power level of anelectromagnetic energy exceeds a exceeds a threshold value. For example,during operation when the input power level is lower than a designatedthreshold level, the optical antifuse 219 remains opaque. When the inputpower level exceeds the designated threshold level, the optical antifuse219 becomes transparent. In an embodiment, the antifuse 219 isconfigured to transition from a non-transmissive state to a transmissivestate by, for example, insulation breakdown.

Non-limiting examples of antifuses 219, or components thereof, may befound in, for example the following documents: U.S. Patent PublicationNo. 2008/0007885 (published Jan. 10, 2008); U.S. Pat. No. 7,714,326(issued May 11, 2010), U.S. Pat. No. 7,691,894 (issued Apr. 6, 2010),and U.S. Pat. No. 7,116,857 (issued Oct. 3, 2006); Davis et al., A NewElectro-Optic Waveguide Architecture and the Unprecedented Devices itEnables, Proc. of SPIE Vol. 6975, pp. 697503-1-12 (2008); Piccolo etal., Antifuse Injectors for SOI LEDs, Proceedings of the 11th AnnualWorkshop on Semiconductor Advances for Future Electronics and Sensors(SAFE 2008), pp. 573-575 (2008); and Vázquez et al., Optical Router forOptical Fiber Sensor Networks Based on a Liquid Crystal Cell, IEEESensors Journal, Vol. 3:(4), pp. 513-518 (2003); each of which isincorporated herein by reference.

In an embodiment, the catheter device 102 includes, among other things,a plurality of selectively actuatable energy waveguides 202 a configuredto selectively actuate via one or more light movable liquid crystals.For example, in an embodiment, during operation, a position of one ormore light movable liquid crystals is altered by impinging a sufficientelectromagnetic energy to cause physical movement of the light movableliquid crystals. Accordingly, one or more of the light movable liquidcrystals are actuated between transmissive and reflective states byinterrogation with electromagnetic energy. Non-limiting examples oflight movable crystals, or components thereof, may be found in, forexample U.S. Pat. No. 7,116,857 (issued Oct. 3, 2006) and U.S. Pat. No.7,197,204 (issued Mar. 27, 2004); each of which is incorporated hereinby reference). In an embodiment, the plurality of selectively actuatableenergy waveguides 202 a are selectively actuatable via one or more lightmovable liquid crystals positionable between at least a transmissiveposition and a reflective position. In an embodiment, the plurality ofselectively actuatable energy waveguides 202 a are selectivelyactuatable via one or more light movable liquid crystals positionablebetween at least an activated position and an inactivated position. Inan embodiment, the plurality of selectively actuatable energy waveguides202 a are selectively actuatable via one or more prisms. In anembodiment, the plurality of selectively actuatable energy waveguides202 a are selectively actuatable via one or more diffractive beamdirecting elements. In an embodiment, the plurality of selectivelyactuatable energy waveguides 202 a are selectively actuatable via one ormore reflective mirrors. In an embodiment, the plurality of selectivelyactuatable energy waveguides 202 a include one or more electromagneticenergy waveguides.

In an embodiment, the system 100 includes, among other things, at leastone router 222 (e.g., energy router, signal router, data packets router,information router, or the like) operably coupled to one or more of theplurality of selectively actuatable energy waveguides 202 a. In anembodiment, the catheter device 102 includes at least one router 222operably coupled to one or more of the plurality of selectivelyactuatable energy waveguides 202 a. In an embodiment, the router 222 isconfigured to actuate via one or more mechanical-optic components,electro-optic components, or acousto-optic components. In an embodiment,the catheter device 102 includes, among other things, at least onerouter 222 operably coupled to one or more energy emitters 220. In anembodiment, at least one router 222 is configured to guide an energystimulus based on one or more selection rules. For example, in anembodiment, the system 100 includes a router 224 operably coupled to atleast one of the one or more energy emitters 220, and configured toguide an energy stimulus based on one or more selection rules.Non-limiting examples of selection rules include routing schemes, energycharacteristics, waveguide-specific destination information, deliveryprotocols, routing metrics, address protocols, waveguide-specificaddresses, or the like.

In an embodiment, two or more of the plurality of selectively actuatableenergy waveguides 202 a are operably coupled to at least one opticalrouter 224. In an embodiment, the optical router 224 includes at leastone switch 218 (e.g., an optical switch, an opto-mechanical switch, anelectro-optic switch, an acousto-optic switch, a thermo-optic switch, orthe like). In an embodiment, the optical router 224 includes at leastone of an electro-mechanical switch, an opto-mechanical switch, anelectro-optic switch, an acousto-optic switch, or a thermo-optic switch.

In an embodiment, the system 100 includes, among other things, at leastone optical router 224 operably coupled to at least one of the one ormore energy emitters via one or more switches 218. In an embodiment, theoptical router 224 is activatable via one or more acousto-opticcomponents, electro-mechanical components, electro-optic components, ormechanical-optic components.

In an embodiment, two or more of the plurality of selectively actuatableenergy waveguides 202 a are operably coupled to at least one passiveoptical router 226. In an embodiment, the at least one passive opticalrouter 226 is configured to guide electromagnetic energy based on atleast one of waveguide-specific address, wavelength, polarization,intensity, or frequency. In an embodiment, the at least one passiveoptical router 226 is configured to guide electromagnetic energy basedon a polarization. In an embodiment, the router 222 includes one or moreswitches 218.

In an embodiment, the system 100 includes, among other things, anovermoded electromagnetic energy waveguide 202 b photonically coupled toone or more of the plurality of selectively actuatable energy waveguides202 a. In an embodiment, the catheter device 102 includes an overmodedelectromagnetic energy waveguide 202 b photonically coupled to one ormore of the plurality of selectively actuatable energy waveguides 202 a.In an embodiment, the overmoded electromagnetic energy waveguide 202 bis configured to selectively actuate one or more of the plurality ofselectively actuatable energy waveguides 202 a. In an embodiment, two ormore of the plurality of selectively actuatable energy waveguides 202 aare selectively actuatable via one or more overmoded electromagneticenergy waveguides 202 b. In an embodiment, the overmoded electromagneticenergy waveguide 202 b is configured to propagate electromagnetic energyin at least a first mode and a second mode different from the firstmode. In an embodiment, the first mode is configured to actuate one ormore of the plurality of selectively actuatable energy waveguides 202 a,and the second mode is configured to actuate a different ones of the oneor more the plurality of selectively actuatable energy waveguides 202 a.In an embodiment, the plurality of selectively actuatable energywaveguides 202 a include one or more single-mode electromagnetic energywaveguides 202 c coupled to an overmoded electromagnetic energywaveguide 202 b. In an embodiment, the plurality of selectivelyactuatable energy waveguides 202 a include one or more single-modeelectromagnetic energy waveguides 202 c coupled to a multimodeelectromagnetic energy waveguide 202 d.

Referring to FIG. 2, in an embodiment, the system 100 includes, amongother things, one or more energy emitters 220. In an embodiment, thecatheter device 102 includes one or more energy emitters 220. In anembodiment, the one or more energy emitters 220 are configured to emitat least one of an electromagnetic stimulus, an electrical stimulus, anacoustic stimulus (e.g., ultrasonic stimulus, or the like), and athermal stimulus. In an embodiment, the one or more energy emitters 220are configured to generate a sterilizing energy stimulus. In anembodiment, the one or more energy emitters 220 are configured todeliver an energy stimulus to a biological sample received within theone or more fluid-flow passageways 110. In an embodiment, the one ormore energy emitters 220 are configured to deliver an emitted energystimulus to a biological sample proximate a surface of catheter device102.

In an embodiment, the one or more energy emitters 220 are configured todeliver an energy stimulus along a substantially longitudinal direction,along a substantially lateral direction, or both of at least one of theone or more fluid-flow passageways 110. In an embodiment, the one ormore energy emitters 220 are configured to deliver a first portion of anemitted energy stimulus along a substantially lateral direction in oneor more regions of at least one of the one or more fluid-flowpassageways 110 and deliver a second portion of the emitted energystimulus along a substantially longitudinal direction in one or moreregions of at least one of the one or more fluid-flow passageways 110.In an embodiment, the one or more energy emitters 220 are configured todeliver at least a portion of an emitted energy stimulus along asubstantially lateral direction in a first region of at least one of theone or more fluid-flow passageways 110 and deliver at least a portion ofthe emitted energy stimulus along a substantially lateral direction in asecond region of the one or more fluid-flow passageways 110, the secondregion different from the first region. In an embodiment, the one ormore energy emitters 220 are configured to deliver at least a portion ofan emitted energy stimulus along a substantially longitudinal directionin a first region of at least one of the one or more fluid-flowpassageways 110 and deliver at least a portion of the emitted energystimulus along a substantially longitudinal direction in a second regionof the one or more fluid-flow passageways 110, the second regiondifferent from the first region. In an embodiment, the one or moreenergy emitters 220 are configured to deliver at least a portion of anemitted energy stimulus along a substantially lateral direction in afirst region of at least one of the one or more fluid-flow passageways110 and at least a portion of the emitted energy stimulus along asubstantially lateral direction in a second region of the one or morefluid-flow passageways 110, the second region different from the firstregion.

In an embodiment, the one or more energy emitters 220 are configured toemit one or more energy stimuli (e.g., one or more electromagneticstimuli, electrical stimuli, acoustic stimuli, and thermal stimuli, orthe like) at a dose sufficient to modulate microbial activity proximatea surface of the catheter device 102. For example, in an embodiment, theone or more energy emitters 220 are configured to emit one or moreenergy stimuli of a dose sufficient to inhibit a DNA replication processof an infectious agent proximate a surface of the catheter device 102.

In an embodiment, the one or more energy emitters 220 are configured todeliver an in vivo stimulus waveform to a biological subject. Forexample, in an embodiment, the one or more energy emitters 220 areconfigured to generate one or more continuous or pulsed energy waves, orcombinations thereof. In an embodiment, the one or more energy emitters220 are configured to deliver a sterilizing energy stimulus to a regionproximate the catheter device 102. In an embodiment, the one or moreenergy emitters 220 are configured to deliver an emitted energy to abiological specimen (e.g., tissue, biological fluid, target sample,infectious agent, or the like) proximate at least one of an outersurface 106 or an inner surface 108 of the catheter device 102.

In an embodiment, the one or more energy emitters 220 are energeticallycoupled to the exterior or interior surfaces 108, 110 of a bodystructure 104 via one or more waveguides 202 (e.g., via one or moreselectively actuatable energy waveguides 202 a). In an embodiment, oneor more of the waveguides 202 are operably coupled to respective energyemitters 220 and are configured to direct an emitted energy stimulusfrom the respective energy emitters 220 to one or more regions proximatethe body structure 104 based on a determined microorganism colonizationevent. In an embodiment, at least one of the one or more energy emitters220 is operably coupled to two or more of the plurality of selectivelyactuatable energy waveguides 202 a. In an embodiment, at least one ofthe one or more energy emitters 220 is operably coupled to three or moreof the plurality of selectively actuatable energy waveguides 202 a.

Energy emitters 220 forming part of the catheter device 102 can take avariety of forms, configurations, and geometrical patterns including forexample, but not limited to, a one-, two-, or three-dimensional arrays,a pattern comprising concentric geometrical shapes, a pattern comprisingrectangles, squares, circles, triangles, polygons, any regular orirregular shapes, or the like, or any combination thereof. One or moreof the energy emitters 220 can have a peak emission wavelength in thex-ray, ultraviolet, visible, infrared, near infrared, terahertz,microwave, or radio frequency spectrum. In an embodiment, at least oneof the one or more energy emitters 220 is configured to deliver one ormore charged particles.

Non-limiting examples of energy emitters 220 include electromagneticenergy emitters 221, acoustic energy emitters 223, thermal energyemitters 225, or electrical energy emitters 227. Further non-limitingexamples of energy emitters 220 include optical energy emitters andultrasound energy emitters. Further non-limiting examples of energyemitters 220 include, electric circuits, electrical conductors,electrodes (e.g., nano- and micro-electrodes, patterned-electrodes,electrode arrays (e.g., multi-electrode arrays, micro-fabricatedmulti-electrode arrays, patterned-electrode arrays, or the like),electrocautery electrodes 225 a, or the like), cavity resonators,conducting traces 227 a, ceramic patterned electrodes,electro-mechanical components, lasers, quantum dots, laser diodes,light-emitting diodes 221 a (e.g., organic light-emitting diodes,polymer light-emitting diodes, polymer phosphorescent light-emittingdiodes, microcavity light-emitting diodes, high-efficiency UVlight-emitting diodes, or the like), arc flashlamps, incandescentemitters, transducers 223 a, heat sources, continuous wave bulbs,ultrasound emitting elements, ultrasonic transducers, thermal energyemitting elements, or the like. In an embodiment, the one or more energyemitters 220 include at least one two-photon excitation component. In anembodiment, the one or more energy emitters 220 include at least one ofan exciplex laser, a diode-pumped solid state laser, or a semiconductorlaser.

Further non-limiting examples of energy emitters 220 include radiationemitters, ion emitters, photon emitters, electron emitters, gammaemitters, or the like. In an embodiment, the one or more energy emitters220 include one or more incandescent emitters, transducers, heatsources, or continuous wave bulbs. In an embodiment, the one or moreenergy emitters 220 include one or more laser, light-emitting diodes,laser diodes, fiber lasers, lasers, or ultra-fast lasers, quantum dots,organic light-emitting diodes, microcavity light-emitting diodes, orpolymer light-emitting diodes.

Further non-limiting examples of energy emitters 220 includeelectromagnetic energy emitters 221. In an embodiment, the catheterdevice 102 includes one or more electromagnetic energy emitters 221. Inan embodiment, the one or more electromagnetic energy emitters 221provide a voltage across at least a portion of cells proximate an outersurface 106 of the catheter device 102. In an embodiment, the one ormore electromagnetic energy emitters 221 include one or more electrodes.In an embodiment, the one or more electromagnetic energy emitters 221include one or more light-emitting diodes 221 a. In an embodiment, theone or more electromagnetic energy emitters 221 include at least oneelectron emitting material.

In an embodiment, the one or more electromagnetic energy emitters 221provide a voltage across at least a portion of tissue proximate thecatheter device 102, and to induce pore formation in a plasma membraneof at least a portion of infectious agents within a region proximate thecatheter device 102. In an embodiment, the voltage is of a dosesufficient to exceed a nominal dielectric strength of at least one cellplasma membrane. In an embodiment, the one or more electromagneticenergy emitters 221 provide a voltage across at least a portion of cellswithin a biological fluid received within at least one of the one ormore fluid-flow passageways 110. In an embodiment, the voltage is ofsufficient strength and duration to exceed a nominal dielectric strengthof at least one cell plasma membrane. In an embodiment, the voltage isof sufficient strength and duration to exceed a nominal dielectricstrength of a cell plasma membrane without substantially interferingwith a normal operation of the implantable shunt system.

Further non-limiting examples of energy emitters 220 include thermalenergy emitters 225. Non-limiting examples of thermal energy emitters225 include transducers 223 a, metallic heat-radiating elements, highpower light-emitting diodes, thermal energy emitting elements, thermalenergy conducting elements, thermal energy dissipating elements,electrodes, or the like. In an embodiment, the one or more thermalenergy emitters 225 are configured to emit a sufficient amount of anenergy stimulus to inactivate an infectious agent. In an embodiment, thecatheter device 102 includes one or more thermal energy emitters 225configured to thermally shock an infectious agent.

Further non-limiting examples of energy emitters 220 include electricalenergy emitters 227. In an embodiment, the one or more electrical energyemitters 227 include at least one electrode 227 a. In an embodiment, aplurality of electrodes 227 a are configured to energize a regionproximate the catheter device 102 in the presence of an appliedpotential. In an embodiment, the applied potential is sufficient toproduce superoxidized water from an aqueous salt composition proximatethe plurality of electrodes 227 a. In an embodiment, the appliedpotential is sufficient to produce at least one of a tripletexcited-state specie, a reactive oxygen specie, a reactive nitrogenspecie, a free radical, a peroxide, or any other inorganic or organicion or molecules that include oxygen ions. Further non-limiting examplesof energy emitters 220 can be found in, for example, U.S. Pat. No.6,488,704 (issued Dec. 3, 2002), which is incorporated herein byreference.

In an embodiment, a plurality of electrodes 227 a provide an electricalenergy stimulus. Electrodes 227 a can take a variety of forms,configurations, and geometrical patterns including for example, but notlimited to, a one-, two-, or three-dimensional arrays, a patterncomprising concentric geometrical shapes, a pattern comprisingrectangles, squares, circles, triangles, polygons, any regular orirregular shapes, or the like, and any combination thereof. Techniquessuitable for making patterned electrodes include, but are not limitedto, electro-deposition, electro-deposition onto laser-drilled polymermolds, laser cutting and electro-polishing, laser micromachining,surface micro-machining, soft lithography, x-ray lithography, LIGAtechniques (e.g., X-ray lithography, electroplating, and molding),conductive paint silk screen techniques, conventional patterningtechniques, injection molding, conventional silicon-based fabricationmethods (e.g., inductively coupled plasma etching, wet etching,isotropic and anisotropic etching, isotropic silicon etching,anisotropic silicon etching, anisotropic GaAs etching, deep reactive ionetching, silicon isotropic etching, silicon bulk micromachining, or thelike), complementary-symmetry/metal-oxide semiconductor (CMOS)technology, deep x-ray exposure techniques, or the like.

In an embodiment, the one or more energy emitters 220 include at leastone light-emitting diode 221 a. In an embodiment, the catheter device102 includes one or more light-emitting diodes 221 a. Light-emittingdiodes 221 a come in a variety of forms and types including, forexample, standard, high intensity, super bright, low current types, orthe like. Typically, the light-emitting diode's color is determined bythe peak wavelength of the light emitted. For example, redlight-emitting diodes have a peak emission ranging from about 610 nm toabout 660 nm. Non-limiting examples of light-emitting diode colorsinclude amber, blue, red, green, white, yellow, orange-red, ultraviolet,or the like. Further non-limiting examples of light-emitting diodesinclude bi-color, tri-color, or the like. Light-emitting diode'semission wavelength may depend on a variety of factors including, forexample, the current delivered to the light-emitting diode. The color orpeak emission wavelength spectrum of the emitted light may alsogenerally depend on the composition or condition of the semi-conductingmaterial used, and can include, among other things, peak emissionwavelengths in the infrared, visible, near-ultraviolet, or ultravioletspectrum, or combinations thereof.

Light-emitting diodes 221 a can be mounted on, for example, but notlimited to a surface, a substrate, a portion, or a component of thecatheter device 102 using a variety of methodologies and technologiesincluding, for example, wire bonding, flip chip, controlled collapsechip connection, integrated circuit chip mounting arrangement, or thelike. In an embodiment, the light-emitting diodes 221 a are mounted on asurface, substrate, portion, or component of the catheter device 102using, for example, but not limited to a flip-chip arrangement. Aflip-chip is one type of integrated circuit chip mounting arrangementthat generally does not require wire bonding between chips. In anembodiment, instead of wire bonding, solder beads or other elements arepositioned or deposited on chip pads such that when the chip is mounted,electrical connections are established between conductive traces carriedby circuitry within the system 100. In an embodiment, the one or moreenergy emitters 220 include one or more light-emitting diode arrays. Inan embodiment, the one or more energy emitters 220 include at least oneof a one-dimensional light-emitting diode array, a two-dimensionallight-emitting diode array, or a three-dimensional light-emitting diodearray.

In an embodiment, the one or more energy emitters 220 include at leastone acoustic energy emitter 223. In an embodiment, the catheter device102 includes one or more acoustic energy emitters 223. In an embodiment,the one or more energy emitters 220 include one or more transducers 223a (e.g., acoustic transducers, electroacoustic transducers,electrochemical transducers, electromagnetic transducers,electromechanical transducers, electrostatic transducers, photoelectrictransducers, radioacoustic transducers, thermoelectric transducers,ultrasonic transducers, or the like). In an embodiment, the one or moretransducers 223 a are configured to deliver an acoustic energy stimulus(e.g., an acoustic non-thermal stimulus, an acoustic thermal stimulus, alow or high intensity acoustic stimulus, a pulsed acoustic stimulus, afocused acoustic stimulus, or the like) to a region within thebiological subject. In an embodiment, the one or more transducers 223 aare configured to generate an ultrasonic stimulus. In an embodiment, theone or more transducers 223 a are configured to detect an acousticsignal. In an embodiment, the one or more transducers 223 a areconfigured to transmit and receive acoustic waves. In an embodiment, theone or more transducers 223 a are configured to deliver an ultrasonicstimulus to a region proximate the catheter device 102. In anembodiment, the one or more transducers 223 a are configured to deliveran in vivo ultrasonic interrogation waveform to a biological subject. Inan embodiment, the one or more transducers 223 a are configured togenerate one or more continuous or a pulsed ultrasonic waves, orcombinations thereof.

Non-limiting examples of transducers 223 a include, among others,acoustic transducers, composite piezoelectric transducers, conformaltransducers, flexible transducers, flexible ultrasonic multi-elementtransducer arrays, flexible ultrasound transducers, immersibleultrasonic transducers, integrated ultrasonic transducers,micro-fabricated ultrasound transducers, piezoelectric materials (e.g.,lead-zirconate-titanate, bismuth titanate, lithium niobate,piezoelectric ceramic films or laminates, sol-gel sprayed piezoelectricceramic composite films or laminates, piezoelectric crystals, or thelike), piezoelectric ring transducers, piezoelectric transducers,ultrasonic sensors, ultrasonic transducers, or the like. In anembodiment, the one or more energy emitters 220 include one or moreone-dimensional transducer arrays, two-dimensional transducer arrays, orthree-dimensional transducer arrays. The one or more transducers 223 acan include, but are not limited to, a single design where a singlepiezoelectric component outputs one single waveform at a time, or can becompound where two or more piezoelectric components are utilized in asingle transducer 223 a or in multiple transducers 223 a therebyallowing multiple waveforms to be output sequentially or concurrently.

The effects of therapeutic ultrasound on living tissues vary. Forexample, ultrasound typically has a greater affect on highly organized,structurally rigid tissues such as bone, tendons, ligaments, cartilage,and muscle. Due to their different depths within the body, however, thedifferent tissue types require different ultrasonic frequencies foreffective treatment. See, e.g., U.S. Publication No. 2007/0249969(published Oct. 25, 2007) (which is incorporated herein by reference).Ultrasound can cause increases in tissue relaxation, local blood flow,and scar tissue breakdown. In an embodiment, the effect of the increasein local blood flow are used to, for example, aid in reducing localswelling and chronic inflammation, as well as promote bone fracturehealing. In an embodiment, applying a sufficient ultrasonic energy totissue infected with, for example, pathogenic bacteria, can lead to areduction of the pathogenic bacteria in at least a portion of theinfected tissue. In an embodiment, applying a sufficient ultrasonicenergy to tissue infected with, for example, pathogenic bacteria, in thepresence of one or more disinfecting agents can lead to a reduction ofthe pathogenic bacteria in at least a portion of the infected tissue. Inan embodiment, applying a sufficient ultrasonic energy to tissueinfected with, for example, pathogenic bacteria, in the presence of oneor more disinfecting agents can reduce biofilm viability, as well asactively-impeding biofilm formation on an implant.

In an embodiment, the system 100 includes electro-mechanical componentsfor generating, transmitting, or receiving waves (e.g., ultrasonicwaves, electromagnetic waves, or the like). For example, in anembodiment, the system 100 includes one or more waveform generators 229,as well as any associated hardware, software, or the like. In anembodiment, the system 100 includes one or more computing devices 230configured to concurrently or sequentially operate multiple transducers223 a. In an embodiment, the system 100 includes multiple drive circuits(e.g., one drive circuit for each transducer 223 a) and is configured togenerate varying waveforms from each coupled transducer 223 a (e.g.,multiple waveform generators, or the like). In an embodiment, the system100 includes, among other things, an electronic timing controllercoupled to an ultrasonic waveform generator. In an embodiment, one ormore computing devices 230 are configured to automatically control oneor more of a frequency, a duration, a pulse rate, a duty cycle, anamount of energy, or the like associated with the ultrasonic energygenerated by the one or more transducers 223 a.

In an embodiment, the one or more transducers 223 a are communicativelycoupled to one or more waveform generators 229. In an embodiment, awaveform generator 229 can include, among other things, an oscillator231 and a pulse generator 233 configured to generate one or more drivesignals for causing one or more transducer 223 a to ultrasonicallyvibrate and generate ultrasonic energy.

In an embodiment, the catheter device 102 employs high intensity focusedultrasound (HIFU) to induce localized heating. For example, in anembodiment, the catheter device 102 includes one or more acoustic energyemitters 223 configured to deliver a high intensity focused ultrasoundstimulus. High acoustic intensities associated with HIFU can cause rapidheat generation in cells and tissue due to absorption of the acousticenergy. Delivering a HIFU stimulus can cause the temperature in a regionincluding cells (e.g., subject cells, intracellularly infected cells,microbial cells, bacterial cell, yeast cells, fungal cells, or the like)and or tissue to rise very rapidly, inducing thermal stressing of atleast one of the targeted cells or tissue which in turn can lead toprogrammed cell death. The degree of thermal stressing of cells may be afunction of the character or duration of the energy stimulus deliveredto induce a temperature change. For example, rapid heating of cellsusing HIFU may be advantageous for rapidly attenuating an infectiousactivity by inducing cell death as opposed to slow increases intemperature to which the cells may become adapted. See, e.g., Somwaru,et al., J. Androl. 25:506-513, 2004; Stankiewicz, et al., J. Biol. Chem.280:38729-38739, 2005; Sodja, et al., J. Cell Sci. 111:2305-2313,(1998); Setroikromo, et al., Cell Stress Chaperones 12:320-330, 2007;Dubinsky, et al., AJR 190:191-199, 2008; Lepock. Int. J. Hyperthermia,19:252-266, 2003; Roti Int. J. Hyperthermia 24:3-15, 2008; Fuchs, etal., “The Laser's Position in Medicine” pp 187-198 in Applied LaserMedicine. Ed. Hans-Peter Berlien, Gerhard J. Muller, Springer-Verlag NewYork, LLC, 2003; each of which is incorporated herein by reference.

In an embodiment, one or more energy emitters 220 are configured to emita sterilizing energy stimulus having one or more peak emissionwavelengths in the infrared, visible, or ultraviolet spectrum, orcombinations thereof. For example, in an embodiment, at least one of theone or more energy emitters 220 comprises a peak emission wavelengthranging from about 100 nanometers to about 400 nanometers. In anembodiment, at least one of the one or more energy emitters 220comprises a peak emission wavelength ranging from about 100 nanometersto about 320 nanometers. In an embodiment, at least one of the one ormore energy emitters 220 comprises an electromagnetic energy peakemission wavelength ranging from about 100 nanometers to about 280nanometers. In an embodiment, at least one of the one or more energyemitters 220 comprises an electromagnetic energy peak emissionwavelength ranging from about 200 nanometers to about 290 nanometers. Inan embodiment, at least one of the one or more energy emitters 220comprises a peak emission wavelength ranging from about 280 nanometersto about 320 nanometers. In an embodiment, at least one of the one ormore energy emitters 220 comprises a peak emission wavelength rangingfrom about 260 nanometers to about 265 nanometers. In an embodiment, atleast one of the one or more energy emitters 220 comprises a peakemission wavelength about 260 nanometers

In an embodiment, an operational fluence of one or more energy emitters220 is less than about 80 milli-joules per square centimeter. In anembodiment, an operational fluence of one or more energy emitters 220 isless than about 35 milli-joules per square centimeter. In an embodiment,an operational fluence of one or more energy emitters 220 is less thanabout 15 milli-joules per square centimeter. In an embodiment, anaverage energy density of one or more energy emitters 220 ranges fromabout less than about 15 milli-joules per square centimeter to aboutless than about 80 milli-joules per square centimeter.

In an embodiment, the one or more energy emitters 220 are configured toemit one or more energy stimuli of at a dose sufficient to induceprogrammed cell death (PCD) (e.g., apoptosis) of at least a portion ofcells proximate the catheter device 102. PCD can be induced using avariety of methodologies and technologies including, for example, usingacoustic energy, electricity, electromagnetic energy, thermal energy,pulsed electric fields, pulsed ultrasound, focused ultrasound, lowintensity ultrasound, ultraviolet radiation, or the like. Localizedheating therapy caused by the delivery of energy, for example via one ormore energy emitters 220, can likewise induce PCD (e.g., apoptosis) ornecrosis of cells or tissue depending upon the temperature experiencedby the cells or tissue. For example, localized heating therapy between40° C. and 60° C. can result in disordered cellular metabolism andmembrane function and in many instances, cell death (e.g., PCD). Ingeneral, at temperatures below 60° C., localized heating is more likelyto induce PCD in cells without substantially inducing necrosis. Attemperatures greater than about 60° C., the likelihood of inducingcoagulation necrosis of cells and tissue increases. Relatively smallincreases in temperature (e.g., a 3° C. increase) above the normalfunctioning temperature of a cell can cause apoptotic cell death. Forexample, temperatures ranging from 40° C. to 47° C. can induce celldeath in a reproducible time and temperature dependent manner in cellsnormally functioning at 37° C.

Non-limiting examples of methodologies and technologies for inducing PCDcan be found the following documents: Abdollahi et al., Apoptosissignals in Lymphoblasts Induced by Focused Ultrasound, FASEB JournalExpress Article doi:10.1096/fj.04-1601fje (Published online Jul. 1,2004); Ashush et al., Apoptosis Induction of Human Myeloid LeukemicCells by Ultrasound Exposure, Cancer Res. 60: 1014-1020 (2000); Beebe etal., Nanosecond, High-intensity Pulsed Electric Fields Induce Apoptosisin Human Cells, The FASEB Journal express article 10.1096/fj.02-0859fje(Published online Jun. 17, 2003); Caricchio et al., Ultraviolet BRadiation-Induced Cell Death: Critical Role of Ultraviolet Dose inInflammation and Lupus Autoantigen Redistribution, J. Immunol., 171:5778-5786 (2003); Fabo et al., Ultraviolet B but not Ultraviolet ARadiation Initiates Melanoma, Cancer Res. 64 (18): 6372-376 (2004); Fentet al., Low intensity Ultrasound-induced Apoptosis in Human GastricCarcinoma Cells, World J Gastroenterol, 14 (31):4873-879 (2008); Hall etal., Nanosecond Pulsed Electric Fields Induce Apoptosis in p53-Wildtypeand p53-Null HCT116 Colon Carcinoma Cells, Apoptosis, 12 (9):1721-31(2007); and Rediske et al., Pulsed Ultrasound Enhances the Killing ofEscherichia coli Biofilms by Aminoglycoside Antibiotics In vivo,Antimicrob. Agents Chemother., 44 (3): 771-72 (2000); each of which isincorporated herein by reference.

In an embodiment, the catheter device 102 is configured to emit asufficient amount of an energy stimulus to induce PCD withoutsubstantially inducing necrosis of a portion of cells in the vicinity ofthe catheter device 102. For example, in an embodiment, the catheterdevice 102 includes one or more energy emitters 220 configured todeliver electromagnetic radiation of a dose sufficient to induce PCDwithout substantially inducing necrosis of a tissue proximate a surface(e.g., an outer surface, inner surface, or the like) of the catheterdevice 102. In an embodiment, at least one of the one or more energyemitters 220 is configured to emit a pulsed energy stimulus of a dosesufficient to induce PCD without substantially inducing necrosis of aninfectious agent within a biological sample proximate the surface of thebody structure 104. In an embodiment, one or more of the energy emitters220 are configured to deliver a sufficient amount of an ultravioletradiation to induce cell death by PCD. In an embodiment, one or more ofthe energy emitters 220 are configured to deliver an effective dose ofoptical energy at which a cell preferentially undergoes PCD compared tonecrosis.

In an embodiment, one or more of the energy emitters 220 are configuredto deliver a thermal sterilizing stimulus (e.g., a pulse thermalsterilizing stimulus, a spatially patterned thermal sterilizingstimulus, a temporally patterned sterilizing stimulus, or the like) of adose sufficient to elevate a temperature of at least a portion of cellsproximate a catheter device 102. Elevating the temperature of amammalian cell, for example, to 43° C. can cause changes in cellularprotein expression and increased PCD.

In an embodiment, the catheter device 102 includes one or more thermalenergy emitters 225 configured to emit a thermal energy stimulus of adose to thermally induce PCD of a portion of infected cells proximatethe catheter device 102. For example, in an embodiment, one or more ofthe thermal energy emitters 225 are operable to emit a sufficient amountof an energy stimulus to increase the temperature of at least a portionof a biological sample received within at least one of the one or morefluid-flow passageways 110 by about 5° C. to about 20° C. In anembodiment, the one or more thermal energy emitters 225 are operable toemit a sufficient amount of an energy stimulus to increase thetemperature of at least a portion of a biological sample received withinat least one of the one or more fluid-flow passageways 110 by about 5°C. to about 6° C.

In an embodiment, at least one of the one or more energy emitters 220 isconfigured to emit an energy stimulus of a dose sufficient to induce PCDin a pathogen within a fluid received within at least one of the one ormore fluid-flow passageways 110. In an embodiment, at least one of theone or more energy emitters 220 is configured to deliver an energystimulus of a dose sufficient to induce poration (e.g., electroporation)of a plasma membrane in at least a portion of cells proximate thecatheter device 102. In an embodiment, the one or more energy emitters220 include at least one ultraviolet energy emitter. In an embodiment,the one or more energy emitters 220 are configured to deliver asufficient amount of an optical energy to initiate ultraviolet energyinduced PCD. In an embodiment, the one or more energy emitters 220include at least one ultraviolet B energy emitter. In an embodiment, theone or more energy emitters 220 include at least one ultraviolet Cenergy emitter. In an embodiment, at least one of the one or more energyemitters 220 is a germicidal light emitter. In an embodiment, at leastone of the one or more energy emitters 220 is an ultraviolet C lightemitting diode.

In an embodiment, the catheter device 102 includes, among other things,one or more energy emitters 220 configured to emit a pulsed thermalsterilizing stimulus of a dose sufficient to induce PCD withoutsubstantially inducing necrosis of at least a portion of cells proximatethe catheter device 102 in response to a detected measurand. In anembodiment, at least one of the one or more energy emitters 220 isconfigured to emit a pulsed thermal sterilizing stimulus of a dosesufficient to induce PCD without substantially inducing necrosis of aninfectious agent within a tissue proximate the catheter device 102 inresponse to a detect level of an infectious agent. In an embodiment, atleast one of the one or more energy emitters 220 is configured todeliver a pulsed thermal sterilizing stimulus of a dose sufficient toinduce thermally enhanced poration of a plasma membrane in at least aportion of cells within a tissue proximate the catheter device 102. Inan embodiment, at least of the one or more energy emitters 220 isconfigured to deliver a pulsed thermal sterilizing stimulus of a dosesufficient to induce poration of a plasma membrane in at least a portionof cells on a surface of the catheter device 102.

In an embodiment, the one or more energy emitters 220 are operable toemit a sufficient amount of a pulsed sterilizing stimulus to increasethe temperature of at least a portion of cells proximate a surface ofthe catheter device 102. In an embodiment, the one or more energyemitters 220 are operable to emit a sufficient amount of a pulsedsterilizing stimulus to increase the temperature of at least a portioncells within a biological sample received within at least one of the oneor more fluid-flow passageways 110. For example, in an embodiment, theone or more energy emitters 220 are operable to emit a sufficient amountof a pulsed thermal sterilizing stimulus to increase the temperature ofat least a portion of cells proximate the catheter device 102 by about3° C. to about 22° C.

In an embodiment, the one or more energy emitters 220 are operable toemit a sufficient amount of a pulsed thermal sterilizing stimulus toincrease the temperature of at least a portion of cells proximate thecatheter device 102 by about 3° C. to about 10° C. In an embodiment, theone or more energy emitters 220 are operable to emit a sufficient amountof a pulsed thermal sterilizing stimulus to increase the temperature ofat least a portion of cells proximate the catheter device 102 by about3° C. to about 4° C.

In an embodiment, at least one of the one or more energy emitters 220 isconfigured to deliver a pulsed thermal sterilizing stimulus of a dosesufficient to elevate a temperature of at least a portion of cellsproximate the catheter device 102 from about 37° C. to less than about60° C. In an embodiment, at least one of the one or more energy emitters220 is configured to deliver a pulsed thermal sterilizing stimulus of adose sufficient to elevate a temperature of at least a portion of cellsproximate the catheter device 102 from about 37° C. to less than about47° C. In an embodiment, at least one of the one or more energy emitters220 is configured to deliver a pulsed thermal sterilizing stimulus 37°C. of a dose sufficient to elevate a temperature of at least a portionof cells proximate the catheter device 102 from about 37° C. to lessthan about 45° C. In an embodiment, at least one of the one or moreenergy emitters 220 is configured to deliver a pulsed thermalsterilizing stimulus of a dose sufficient to elevate a temperature of atleast a portion of cells proximate the catheter device 102 from about37° C. to less than about 42° C. In an embodiment, at least one of theone or more energy emitters 220 is configured to deliver a pulsedthermal sterilizing stimulus of a dose sufficient to elevate atemperature of at least a portion of cells proximate the catheter device102 from about 37° C. to a temperature ranging from greater than about41° C. to less than about 63° C.

In an embodiment, the one or more energy emitters 220 are configured todirect optical energy along the optical path for a duration sufficientto interact with a biological sample received within one or morefluid-flow passageways 110. For example, in an embodiment, the one ormore energy emitters 220 are configured to generate one or morenon-ionizing laser pulses in an amount and for a duration sufficient toinduce the formation of sound waves associated with changes in abiological mass present along an optical path. In an embodiment, the oneor more energy emitters 220 are configured to direct a pulsed opticalenergy waveform along an optical path of a dose sufficient to cause abiological mass, a portion of cells, a sample, or the like within afocal volume interrogated by the pulsed optical energy waveform totemporarily expand. In an embodiment, the one or more energy emitters220 are configured to direct a pulsed optical energy stimulus along anoptical path in an amount and for a duration sufficient to elicit theformation of acoustic waves associated with changes in a biological masspresent along the optical path.

In an embodiment, the one or more energy emitters 220 are configured todirect a pulsed optical energy waveform along an optical path of a dosesufficient to cause at least a portion of cells within a focal volumeinterrogated by the pulsed optical energy waveform to temporarilyexpand. In an embodiment, the one or more energy emitters 220 areconfigured to direct a pulsed optical energy waveform along an opticalpath in an amount and for a duration sufficient to cause at least aportion of cells within a focal volume interrogated by the pulsedoptical energy waveform to temporarily fluoresce. In an embodiment, theone or more energy emitters 220 are further configured to direct aportion of an emitted optical energy to a sensor component in opticalcommunication along the optical path.

In an embodiment, the one or more energy emitters 220 are concurrentlyor sequentially deliver one or more electromagnetic stimuli, electricalstimuli, acoustic stimuli, or thermal stimuli, in vivo, to at least oneof a target sample, a biological sample, an infectious agent, or thelike received within at least one of the one or more fluid-flowpassageways 110. In an embodiment, at least one of the one or moreenergy emitters 220 is photonically coupleable to at least one of aninterior or an exterior of one or more of the one or more fluid-flowpassageways 110 via one or more energy waveguides 202. In an embodiment,at least one of the one or more energy emitters 220 is configured toemit an energy stimulus from an interior of at least one of the one ormore fluid-flow passageways to an exterior of at least one of the one ormore fluid-flow passageways 110.

In an embodiment, the one or more energy emitters 220 provide a voltageacross at least a portion of cells in the vicinity of the catheterdevice 102. In an embodiment, the voltage is of a dose sufficient toexceed a nominal dielectric strength of at least one cell plasmamembrane. In an embodiment, the voltage is of a dose sufficient toexceed a nominal dielectric strength of a cell plasma membrane withoutsubstantially interfering with a normal operation of the implantableshunt system 100 or the catheter device 102.

In an embodiment, the one or more energy emitters 220 are implantedwithin a biological subject. In an embodiment, the one or more energyemitters 220 are configured to apply energy (e.g., electrical energy,electromagnetic energy, thermal energy, ultrasonic energy, or the like,or combinations thereof) to tissue proximate a catheter device 102 to,for example, treat or prevent an infection (e.g., an implant-associatedinfection, hematogenous implant-associated infection, or the like), ahematological abnormality, or the like. In an embodiment, the one ormore energy emitters 220 are configured to apply energy to tissueproximate a catheter device 102 to promote at least one of a tissuehealing process, a tissue growing process, a tissue scarring process, orthe like. In an embodiment, the one or more energy emitters 220 areconfigured to apply energy of a dose sufficient to tissue proximate animplant to inhibit a tissue scarring process. In an embodiment, the oneor more energy emitters 220 are configured to apply energy to tissueproximate an implant to treat, prevent, inhibit, or reducepost-operative adhesion, fibrin sheath formation, or scar tissueformation. In an embodiment, the one or more energy emitters 220 areconfigured to apply an energy stimulus to tissue proximate a catheterdevice 102 to treat, prevent, inhibit, or reduce the presence orconcentration of an infectious agent within at least a portion of thetissue proximate the catheter device 102.

In an embodiment, the one or more energy emitters 220 are concurrentlyor sequentially deliver at least a first energy stimulus and a secondenergy stimulus, the second energy stimulus different from the firstenergy stimulus. In an embodiment, the second energy stimulus differs inat least one of a spatial energy distribution and a temporal energydistribution. In an embodiment, the first energy stimulus comprises anelectromagnetic energy stimulus, an electrical energy stimulus, anultrasonic energy stimulus, or a thermal energy stimulus, and the secondenergy stimulus comprises a different one of an electromagnetic energystimulus, an electrical energy stimulus, an ultrasonic energy stimulus,or a thermal energy stimulus.

In an embodiment, at least one of the one or more energy emitters 220 isconfigured to provide an illumination pattern comprising at least afirst region and a second region. In an embodiment, the second regionincludes at least one of an illumination intensity, an energy-emittingpattern, a peak emission wavelength, an ON-pulse duration, an OFF-pulseduration, or a pulse frequency different from the first region. In anembodiment, the second region includes at least one of a spatial patternor a temporal pattern different from the first region.

In an embodiment, at least one of the one or more energy emitters 220 isoperably coupled to a plurality of energy waveguides 202 (e.g., aplurality of selectively actuatable energy waveguides 202 a, or thelike) that are configured to deliver a spatially or temporally patternedenergy stimulus. In an embodiment, at least one of the one or moreenergy emitters 220 is configured to emit a multiplex energy stimulushaving two or more peak emission wavelengths. In an embodiment, amultiplex energy stimulus can be routed to respective waveguides 202based on a wavelength, an intensity, a spectral power distribution, awaveguide-specific address, a polarization, or the like. In anembodiment, the catheter device 102 includes one or more polarizationrotators operably coupled to at least one of the one or more energyemitters 220. In an embodiment, at least one of the one or more energyemitters 220 is operably coupled to one or more polarization rotators.

In an embodiment, the system 100 includes, among other things, one ormore energy emitters 220 configured to provide a spatially patternedenergy stimulus having at least a first region and a second regiondifferent from the first region. In an embodiment, the first regioncomprises one of a spatially patterned electromagnetic energy stimulus,a spatially patterned electrical energy stimulus, a spatially patternedultrasonic energy stimulus, or a spatially patterned thermal energystimulus, and the second region comprises a different one of a spatiallypatterned electromagnetic energy stimulus, a spatially patternedelectrical energy stimulus, a spatially patterned ultrasonic energystimulus, or a spatially patterned thermal energy stimulus. In anembodiment, the second region comprises at least one of an emissionintensity, an emission phase, an emission polarization, or an emissionwavelength different from the first region. In an embodiment, the secondregion comprises a peak irradiance different from the first region.

In an embodiment, the system 100 includes one or more spatiallypatterned energy emitters 235. In an embodiment, the system 100includes, among other things, one or more spaced-apart energy emitters237. In an embodiment, the system 100 includes, among other things, oneor more patterned energy emitters 239. Patterned energy emitters 239 canbe sized and shaped to provide a spatially patterned energy stimulus to,for example, a region proximate a catheter device 102. In an embodiment,a plurality of energy emitters 220 provides a spatially patterned energystimulus. The spatially patterned energy stimulus can take a varietyforms, configurations, and geometrical patterns including for example,but not limited to, lines, circles, ellipses, triangles, rectangles,polygons, any regular or irregular geometrical patterns, one-dimensionalpatterns, two-dimensional patterns, three-dimensional patterns, or thelike, and any combination thereof. In an embodiment, a plurality ofenergy emitters 220 includes a patterned energy-emitting source. In anembodiment, at least one of the one or more energy emitters 220 includesat least one of a patterned electromagnetic energy-emitting source, apatterned electrical energy-emitting source, a patterned ultrasonicenergy-emitting source, or a patterned thermal energy-emitting source.In an embodiment, at least one of the one or more energy emitters 220includes a patterned electrode.

In an embodiment, the catheter device 102 includes at least a firstenergy emitter and a second energy emitter. In an embodiment, the secondenergy emitter is configured to emit an energy stimulus having anemission wavelength different from an energy stimulus emitted by thefirst energy emitter. In an embodiment, the second energy emitter isconfigured to emit an energy stimulus having a polarization differentfrom an energy stimulus emitted by the first energy emitter.

In an embodiment, one or more of the energy emitters 220 are configuredto concurrently or sequentially emit at least a first energy stimulus toan interior 108 of one or more fluid-flow passageways 104 and a secondenergy stimulus to an exterior 106 of one or more fluid-flowpassageways. In an embodiment, the catheter device 102 includes anoptical component that directs at least a portion of an emitted energystimulus from one or more of the energy emitters 220 to one or more ofthe plurality of selectively actuatable energy waveguides 202 a.

In an embodiment, the at least one of the one or more energy emitters220 is operably coupled to a router 222 having an output directed to twoor more of the plurality of selectively actuatable energy waveguides 202a. In an embodiment, the at least one of the one or more energy emitters220 is operably coupled to an optical router 224 having one or moreoutputs directed to two or more of a plurality of selectively actuatableenergy waveguides 202 a.

In an embodiment, the at least one of the one or more energy emitters220 is operably coupled to a first electromagnetic energy waveguide thatis operably coupled to two or more of a selectively actuatable energywaveguides 202 a. In an embodiment, the at least one of the one or moreenergy emitters 220 is operably coupled to a first electromagneticenergy waveguide that is operably coupled to an optical router 224having one or more outputs directed to two or more of a plurality ofselectively actuatable energy waveguides 202 a. In an embodiment, atleast one of the one or more energy emitters 220 is photonically coupledto one or more of the plurality of selectively actuatable energywaveguides 202 a. In an embodiment, the at least one of the one or moreenergy emitters 220 is photonically coupled to an interior environmentof the body structure 104 via at least one of the plurality ofselectively actuatable energy waveguides 202 a. In an embodiment, atleast one of the one or more energy emitters 220 is photonically coupledto an exterior environment of the body structure 104 via at least one ofthe plurality of selectively actuatable energy waveguides 202 a. In anembodiment, at least one of the one or more energy emitters 220 isconfigured to emit an energy stimulus from an interior to an exterior ofat least one of the one or more fluid-flow passageways 110.

In an embodiment, one or more of the energy emitters 220 are configuredto concurrently or sequentially provide one or more electromagneticstimuli, electrical stimuli, ultrasonic stimuli, or thermal stimuli. Inan embodiment, one or more of the energy emitters 220 are configured toconcurrently or sequentially provide at least a first energy stimulusand a second energy stimulus.

In an embodiment, the second energy stimulus differs from the firstenergy stimulus. For example, in an embodiment, the second energystimulus includes an electromagnetic energy stimulus, an electricalenergy stimulus, an ultrasonic energy stimulus, or a thermal energystimulus different from the first energy stimulus. In an embodiment, thesecond energy stimulus includes at least one of a peak emissionwavelength, a repetition rate, or a bandwidth different from the firstenergy stimulus. In an embodiment, the second energy stimulus includesat least one of an irradiance, a spectral power distribution, or a peakpower different from the first energy stimulus.

In an embodiment, the system 100 includes, among other things, aplurality of independently addressable energy emitting components 274disposed along a longitudinal axis of the catheter device 102. In anembodiment, the independently addressable energy emitting components 274include one or more waveguides 202 operably coupled to one or moreenergy emitters 220. In an embodiment, the plurality of independentlyaddressable energy emitting components 274 is configured to direct anemitted energy stimulus to one or more regions proximate at least one ofthe outer surface and the inner surface of the body structure 104. In anembodiment, one or more of the plurality of independently addressableenergy emitting components 274 are operably coupled to respective energyemitters 220 and are configured to direct an emitted energy stimulusfrom the respective energy emitters 220 to one or more regions proximatethe body structure 104 based on a determined microorganism colonizationevent. In an embodiment, one or more of the plurality of independentlyaddressable energy emitting components 274 are operably coupled torespective energy emitters 220 and are configured to direct an emittedenergy stimulus from the respective energy emitters 220 to one or moreregions proximate at least one of the outer surface 106 and the innersurface 108 of the body structure 104 based on a determinedmicroorganism colonization event.

In an embodiment, the system 102 includes actuating means 272 forconcurrently or sequentially actuating two or more of the plurality ofindependently addressable energy emitting components 274 in one or moreregions determined to have a microorganism colonization event. In anembodiment, the actuating means 272 includes one or more switches 218.In an embodiment, the actuating means 272 includes one or more switches218 operably coupled to one or more computing devices. In an embodiment,the actuating means 272 includes at least one computing device 230configured to generate a response that causes a switching element toestablish or interrupt a connection between the selectively actuatableenergy waveguides and respective one or more energy emitters 220.

In an embodiment, the one or more switches 218 include at least oneacoustically active material. In an embodiment, the one or more switches218 include at least one electro-mechanical switch. In an embodiment,the one or more switches 218 include at least one electro-optic switch.In an embodiment, the one or more switches 218 include at least oneacousto-optic switch. In an embodiment, the one or more switches 218include at least one optical switch. In an embodiment, the actuatingmeans 272 includes at least one of an electro-mechanical switch, anelectro-optic switch, an acousto-optic switch, or an optical switch.

In an embodiment, the actuating means 272 includes at least onecomputing device 230 operably coupled to one or more switches. In anembodiment, the actuating means 272 includes at least one opticalantifuse. In an embodiment, the actuating means 272 includes a movablecomponent having an optical energy reflecting substrate. In anembodiment, the movable component is actuated by an electromagneticenergy stimulus generated by one or more energy emitters 220, andconfigured to guide an optical energy along at least one of theplurality of independently addressable energy emitting components 274when actuated. In an embodiment, the actuating means 272 is configuredto concurrently or sequentially actuate two or more of the plurality ofindependently addressable energy emitting components 274 in one or moreregions based on a determined microorganism colonization event.

With continued reference to FIG. 2, in an embodiment the system 100includes, among other things, at least one computing device 230including one or more processors 232 (e.g., microprocessors), centralprocessing units (CPUs) 234, digital signal processors (DSPs) 236,application-specific integrated circuits (ASICs) 238, field programmablegate arrays (FPGAs) 240, controllers, or the like, or any combinationsthereof, and can include discrete digital or analog circuit elements orelectronics, or combinations thereof. In an embodiment, the system 100includes, among other things, one or more field programmable gate arrays240 having a plurality of programmable logic components. In anembodiment, the system 100 includes, among other things, one or moreapplication specific integrated circuits having a plurality ofpredefined logic components.

In an embodiment, at least one computing device 230 is operably coupledto one or more energy emitters 220 and one or more energy waveguide 202.In an embodiment, the system 100 includes one or more computing devices230 configured to concurrently or sequentially operate multiple energyemitters 220. In an embodiment the computing device 230 comprises atleast one controller. In an embodiment, at least one computing device230 is operably coupled to one or more energy waveguide 202. In anembodiment, one or more of the energy waveguides 202 are configured forselectively actuation via one or more computing devices 230.

In an embodiment, the system 100 includes one or more catheter devices102 including, among other things, one or more receivers 280,transceivers 282, or transmitters 284. In an embodiment, at least one ofthe one or more receiver 280, transceivers 282, and transmitters 284,can be, for example, wirelessly coupled to a computing device 230 thatcommunicates with a control unit of the system 100 via wirelesscommunication. In an embodiment, at least one of the one or morereceivers 280 and transceivers 282 is configured to acquire informationassociated with a set of targets, markers, or the like for detection. Inan embodiment, at least one of the one or more receivers 280 andtransceivers 282 is configured to acquire information associated with aset of physiological characteristic for detection. In an embodiment, atleast one of the one or more receivers 280 and transceivers 282 isconfigured to acquire information associated with one or morephysiological characteristics for detection. In an embodiment, at leastone of the one or more receivers 280 and transceivers 282 is configuredto acquire information associated with one or more cerebrospinal fluidcharacteristics for detection.

In an embodiment, at least one receiver 280 is configured to acquireinformation associated with a delivery of an energy stimulus. In anembodiment, the at least one receiver 280 is configured to acquire data.In an embodiment, the at least one receiver 280 is configured to acquiresoftware. In an embodiment, the at least one receiver 280 is configuredto receive data from one or more distal sensors. In an embodiment, theat least one receiver 280 is configured to receive stored referencedata. In an embodiment, the at least one receiver 280 is configured toacquire at least one of instructions, instructions associated with adelivery of an energy stimulus, instructions associated with a deliveryof an active agent, information associated with a biological sample,instructions associated with a biological fluid, instructions associatedwith a disease state, or the like.

In an embodiment, the at least one receiver 280 is configured to acquireinformation based at least in part on a detected characteristicassociated with a cerebrospinal fluid received within at least one ofthe one or more fluid-flow passageways 110. In an embodiment, the atleast one receiver 280 is configured to acquire information based atleast in part on a detected characteristic associated with a tissueproximate the one or more fluid-flow passageways 110. In an embodiment,the at least one receiver 280 is configured to acquire information basedat least in part on a detected physiological characteristic associatedwith the biological subject. In an embodiment, the at least one receiver280 is configured to acquire information associated with delivery of anactive agent.

In an embodiment, the system 100 includes one or more receivers 280configured to acquire spectral information (e.g., radio frequency (RF)information) emitted by an in vivo biological sample. In an embodiment,the one or more receivers 280 include one or more of analog-to-digitalconverters, signal amplifier, matching networks, oscillators, poweramplifiers, RF receive coils, RF synthesizers, or signal filters. In anembodiment, the system 100 includes one or more transceivers 282 (e.g.,RF transceivers) configured to generate RF excitation pulses thatinteracts with, for example, an in vivo target.

In an embodiment, the system 100 includes control circuitry operablycoupled to the one or more selectively actuatable energy waveguides 202a and configured to control at least one of a spaced-apart configurationparameter, an electromagnetic energy spatial distribution parameter, oran electromagnetic energy temporal distribution parameter associatedwith the delivery of the patterned energy stimulus. In an embodiment, atleast one computing device 230 is operably coupled to one or moreselectively actuatable energy waveguides 202 a and configured to controlat least one of a delivery regiment, a spatial distribution, or atemporal distribution associated with the delivery of the patternedenergy stimulus. In an embodiment, the one or more computing devices 230are configured to actuate at least one of the plurality of selectivelyactuatable energy waveguides 202 a in response to a scheduled program,an external command, a history of a previous microbial presence, or ahistory of a previous actuation.

In an embodiment, one or more computing devices 230 are configured toautomatically control at least one waveform characteristic (e.g.,intensity, frequency, peak power, spectral power distribution, pulseintensity, pulse duration, pulse ratio, pulse repetition rate, or thelike) associated with the delivery of one or more energy stimuli. Forexample, pulsed waves can be characterized by the fraction of time theenergy stimulus is present over one pulse period. This fraction iscalled the duty cycle and is calculated by dividing the pulse time ON bythe total time of a pulse period (e.g., time ON plus time OFF). In anembodiment, a pulse generator 242 is configured to electronicallygenerate pulsed periods and non-pulsed (or inactive) periods.

In an embodiment, the system 100 includes one or more catheter devices102 including for example, but not limited to, circuitry for providinginformation. In an embodiment, the circuitry for providing informationincludes circuitry for providing status information regarding theimplantable device. In an embodiment, the circuitry for providinginformation includes circuitry for providing information regarding atleast one characteristic associated with a biological subject. Forexample, in an embodiment, the circuitry for providing informationincludes circuitry for providing information regarding at least onecharacteristic associated with a tissue or biological fluid proximatethe catheter device 102. In an embodiment, the circuitry for providinginformation includes circuitry for providing information regarding atleast one physiological characteristic associated with the biologicalsubject. In an embodiment, the circuitry for providing informationincludes circuitry for providing information regarding at least onecharacteristic associated with a biological sample of the biologicalsubject. In an embodiment, the circuitry for providing informationincludes circuitry for providing information regarding at least onecharacteristic associated with a tissue proximate the one or morefluid-flow passageways 110. In an embodiment, the system 100 includesone or more catheter devices 102 including for example, but not limitedto, circuitry for transmitting information. In an embodiment, the atleast one transmitter 284 is configured to send information based atleast in part on a detected characteristic associated with acerebrospinal fluid received within at least one of the one or morefluid-flow passageways 110. In an embodiment, the at least onetransmitter 284 is configured to send a request for transmission of atleast one of data, a command, an authorization, an update, or a code.

In an embodiment, the system 100 includes one or more catheter devices102 including for example, but not limited to, one or more cryptographiclogic components 286. In an embodiment, at least one of the one or morecryptographic logic components 286 are configured to implement at leastone cryptographic process, or cryptographic logic, or combinationsthereof. Non-limiting examples of a cryptographic process include one ormore processes associated with cryptographic protocols, decryptionprotocols, encryption protocols, regulatory compliance protocols (e.g.,FDA regulatory compliance protocols, or the like), regulatory useprotocols, authentication protocols, authorization protocols, treatmentregimen protocols, activation protocols, encryption protocols,decryption protocols, or the like. Non-limiting examples of acryptographic logic include one or more crypto-algorithms signal-bearingmedia, crypto controllers (e.g., crypto-processors), cryptographicmodules (e.g., hardware, firmware, or software, or combinations thereoffor implementing cryptographic logic, or cryptographic processes), orthe like.

In an embodiment, the cryptographic logic component 286 is configured toimplement at least one cryptographic process or cryptographic logic. Inan embodiment, the cryptographic logic component 286 is configured toimplement one or more processes associated with at least one of acryptographic protocol, a decryption protocol, an encryption protocol, aregulatory compliance protocol, a regulatory use protocol, anauthentication protocol, an authorization protocol, a delivery protocol,an activation protocol, an encryption protocol, or a decryptionprotocol. In an embodiment, the cryptographic logic component 286includes one or more crypto-algorithms, signal-bearing media, cryptocontrollers, or cryptographic modules.

In an embodiment, the cryptographic logic component 286 is configured togenerate information associated with at least one of an authenticationprotocol, an authorization protocol, a delivery protocol (e.g., asterilizing energy stimulus delivery protocol), an activation protocol,an encryption protocol, or a decryption protocol. In an embodiment, thecryptographic logic component 286 is configured to generate informationassociated with at least one of an authorization instruction, anauthentication instruction, a prescription dosing instruction, asterilizing energy stimulus administration instruction, or a prescribedregimen instruction.

In an embodiment, the cryptographic logic component 286 is configured togenerate information associated with at least one of an instructionstream, an encrypted data stream, an authentication data stream, or anauthorization data stream. In an embodiment, the cryptographic logiccomponent 286 is configured to generate information associated with atleast one of an activation code, an error code, a command code, or anauthorization code. In an embodiment, the cryptographic logic component286 is configured to generate information associated with at least oneof a cryptographic protocol, a decryption protocol, an encryptionprotocol, a regulatory compliance protocol, or regulatory use protocol.

In an embodiment, the system 100 includes at least one computing device230 communicably coupled to one or more energy emitters 220 andconfigured to control at least one of a duration time, an amount ofenergy (e.g., a fluence, peak power, average power, spectral powerdistribution, operational fluence, or the like), a delivery schedule, adelivery pattern, a delivery regimen, an excitation amount, anexcitation type, or a delivery location associated with the delivery ofan energy stimulus. In an embodiment, the system 100 includes at leastone computing device 230 communicably coupled to one or more energywaveguides 202, and configured to control at least one parameterassociated with selectively actuating one or more energy waveguides 202.

For example, in an embodiment, the computing device 230 is configured tocontrol at least one parameter associated with an emission intensity, anemission phase, an emission polarization, an emission power, or anemission wavelength of an energy stimulus. In an embodiment, thecomputing device 230 is configured to control at least one parameterassociated with an intensity, an irradiance (I_(n)), a peak power(P_(n)), a phase, a polarization, or a spectral power distribution(SPD_(n)) of an energy stimulus. In an embodiment, the computing device230 is configured to control at least one parameter associated with aspatial illumination field modulation, a spatial illumination fieldintensity, or a spatial illumination delivery pattern. In an embodiment,the computing device 230 is configured to control at least one of anexcitation intensity, an excitation frequency, an excitation pulsefrequency, an excitation pulse ratio, an excitation pulse intensity, anexcitation pulse duration time, an excitation pulse frequency, or anexcitation pulse repetition rate. In an embodiment, the computing device230 is configured to control at least one of a bandwidth, a frequency, arepetition rate, an energy-emitting pattern, an OFF-pulse duration, anOFF-rate, an ON-pulse duration, or an ON-rate.

In an embodiment, the catheter device 102 is, for example, wirelesslycoupled to a computing device 230 that communicates with the catheterdevice 102 via wireless communication. Non-limiting examples of wirelesscommunication include optical connections, ultraviolet connections,infrared, BLUETOOTH®, Internet connections, radio, network connections,or the like.

In an embodiment, the catheter device 102 includes at least onecomputing device 230 configured to control one or more parameterassociated with the operation of the catheter device 102. For example,in an embodiment, the catheter device 102 includes at least onecomputing device 230 operably coupled to one or more of the energyemitters 220 and configured to control at least one parameter associatedwith the delivery of the energy stimulus. In an embodiment, the at leastone computing device 230 is configured to control at least one of aduration time, an amount of energy, an excitation amount, an excitationtype, a delivery location, or a spatial-pattern stimulationconfiguration associated with the delivery of the energy stimulus.

In an embodiment, the system 100 includes, among other things, one ormore memories 250 that, for example, store instructions or data, forexample, volatile memory (e.g., Random Access Memory (RAM) 252, DynamicRandom Access Memory (DRAM), or the like), non-volatile memory (e.g.,Read-Only Memory (ROM) 254, Electrically Erasable Programmable Read-OnlyMemory (EEPROM), Compact Disc Read-Only Memory (CD-ROM), or the like),persistent memory, or the like. Further non-limiting examples of one ormore memories 250 include Erasable Programmable Read-Only Memory(EPROM), flash memory, or the like. Various components of the catheterdevice 102 (e.g., memories 250, processors 232, or the like) can beoperably coupled to each other via one or more instruction, data, orpower buses 256.

In an embodiment, the system 100 includes, among other things, one ormore databases 258. In an embodiment, a database 258 includes spectralinformation configured as a physical data structure. In an embodiment, adatabase 258 includes at least one of inflammation indication parameterdata, infection indication parameter data, diseased tissue indicationparameter data, or the like. In an embodiment, a database 258 includesat least one of absorption coefficient data, extinction coefficientdata, scattering coefficient data, or the like. In an embodiment, adatabase 258 includes at least one of stored reference data such asinfection marker data, inflammation marker data, infective stress markerdata, a systemic inflammatory response syndrome data, sepsis markerdata, or the like.

In an embodiment, a database 258 includes information associated with adisease state of a biological subject. In an embodiment, a database 258includes measurement data. In an embodiment, a database 258 includes atleast one of psychosis state indication information, psychosis traitindication information, or predisposition for a psychosis indicationinformation. In an embodiment, a database 258 includes at least one ofinfection indication information, inflammation indication information,diseased state indication information, or diseased tissue indicationinformation. In an embodiment, a database 258 includes at least one ofcryptographic protocol information, regulatory compliance protocolinformation (e.g., FDA regulatory compliance protocol information, orthe like), regulatory use protocol information, authentication protocolinformation, authorization protocol information, delivery regimenprotocol information, activation protocol information, encryptionprotocol information, decryption protocol information, treatmentprotocol information, or the like. In an embodiment, a database 258includes at least one of energy stimulus control delivery information,energy emitter 220 control information, power control information,energy waveguide 202 control information, or the like.

In an embodiment, the system 100 is configured to compare an inputassociated with at least one characteristic associated with a biologicalsubject to a database 258 of stored reference values, and to generate aresponse based in part on the comparison. In an embodiment, the system100 is configured to compare an input associated with at least onephysiological characteristic associated with a biological subject to adatabase 258 of stored reference values, and to generate a responsebased in part on the comparison.

In an embodiment, the at least one characteristic associated with abiological subject includes real-time detected information associatedwith a sample (e.g., tissue, biological fluid, infections agent,biomarker, or the like) proximate a catheter device 102. In anembodiment, the at least one characteristic associated with a biologicalsubject includes a measurand detected at a plurality of time intervals.In an embodiment, the at least one characteristic associated with abiological subject includes real-time detected information associatedwith a sample (e.g., a biological fluid) received within one or morefluid-flow passageways 110.

In an embodiment, the system 100 is configured to compare an inputassociated with at least one characteristic associated with a biologicalsample proximate the catheter device 102 (e.g., received within one ormore fluid-flow passageways 110, on or near a surface of the bodystructure 104, or the like) to a database 258 of stored referencevalues, and to generate a response based in part on the comparison. Inan embodiment, the response includes at least one of a visualrepresentation, an audio representation (e.g., an alarm, an audiowaveform representation of a tissue region, or the like), a hapticrepresentation, and a tactile representation (e.g., a tactile diagram, atactile display, a tactile graph, a tactile interactive depiction, atactile model (e.g., a multidimensional model of an infected tissueregion, or the like), a tactile pattern (e.g., a refreshable Brailledisplay), a tactile-audio display, a tactile-audio graph, or the like).In an embodiment, the response includes generating at least one of avisual, an audio, a haptic, or a tactile representation of biologicalsample spectral information (e.g., biological fluid spectralinformation, tissue spectral information, fat spectral information,muscle spectral information, bone spectral information, blood componentspectral information, biomarker spectral information, infectious agentspectral information, or the like). In an embodiment, the responseincludes generating at least one of a visual, an audio, a haptic, or atactile representation of at least one physical or biochemicalcharacteristic associated with a biological subject.

In an embodiment, the response includes initiating one or more treatmentprotocols. In an embodiment, the response includes activating one ormore sterilization protocols. In an embodiment, the response includesinitiating at least one treatment regimen. In an embodiment, theresponse includes delivering an energy stimulus. In an embodiment, theresponse includes delivering an active agent. In an embodiment, theresponse includes concurrently or sequentially delivering an energystimulus and an active agent.

In an embodiment, the response includes at least one of a responsesignal, a control signal, a change to a sterilizing stimulus parameter(e.g., an electrical sterilizing stimulus, an electromagneticsterilizing stimulus, an acoustic sterilizing stimulus, or a thermalsterilizing stimulus), or the like. In an embodiment, the responseincludes at least one of a change in an excitation intensity, a changein an excitation frequency, a change in an excitation pulse frequency, achange in an excitation pulse ratio, a change in an excitation pulseintensity, a change in an excitation pulse duration time, a change in anexcitation pulse repetition rate, or the like.

In an embodiment, the response includes at least one of a change to asterilizing stimulus spatial pattern parameter (e.g., an electricalsterilizing stimulus spatial pattern parameter, an electromagneticsterilizing stimulus spatial pattern parameter, an acoustic sterilizingstimulus spatial pattern parameter, or a thermal sterilizing stimulusspatial pattern parameter), or a change in a sterilizing stimulusdelivery regiment parameter (e.g., an electrical sterilizing stimulusdelivery regiment parameter, an electromagnetic sterilizing stimulusdelivery regiment parameter, an acoustic sterilizing stimulus deliveryregiment parameter, or a thermal sterilizing stimulus delivery regimentparameter), or the like.

In an embodiment, the response includes at least one of activating anauthorization protocol, activating an authentication protocol,activating a software update protocol, activating a data transferprotocol, or activating an infection sterilization diagnostic protocol.In an embodiment, the response includes sending information associatedwith at least one of an authentication protocol, an authorizationprotocol, a delivery protocol, an activation protocol, an encryptionprotocol, or a decryption protocol.

In an embodiment, a database 258 includes at least one of storedreference data such as characteristic biological sample (e.g.,cerebrospinal fluid) component signature data, characteristic bloodcomponent signature data, characteristic tissue signature data, or thelike. In an embodiment, a database 258 includes information indicativeof one or more spectral events associated with transmitted opticalenergy or a remitted optical energy from at least one of a biologicaltissue or biological fluid.

In an embodiment, a database 258 includes at least one of cerebrospinalfluid spectral information, blood spectral information, tissue spectralinformation, fat spectral information, muscle spectral information, andbone spectral information. In an embodiment, a database 258 includes atleast one of modeled tissue (e.g., blood, bone, muscle, tendons, organs,fluid-filled cysts, ventricles, or the like) spectral information ormodeled biological fluid spectral information. In an embodiment, adatabase 258 includes modeled biological sample spectral information.

In an embodiment, a database 258 includes at least one of inflammationindication parameter data, infection indication parameter data, diseasedtissue indication parameter data, or the like. In an embodiment, adatabase 258 includes at least one of absorption coefficient data,extinction coefficient data, scattering coefficient data, or the like.In an embodiment, a database 258 includes stored reference data such ascharacteristic spectral signature data. In an embodiment, a database 258includes stored reference data such as infection marker data,inflammation marker data, infective stress marker data, a systemicinflammatory response syndrome data, sepsis marker data, or the like. Inan embodiment, a database 258 includes information associated with adisease state of a biological subject. In an embodiment, a database 258includes user-specific measurement data.

In an embodiment, the system 100 is configured to compare an inputassociated with a biological subject to a database 258 of storedreference values, and to generate a response based in part on thecomparison. In an embodiment, the system 100 is configured to compare anoutput of one or more of the plurality of logic components and todetermine at least one parameter associated with a cluster centroiddeviation derived from the comparison. In an embodiment, the system 100is configured to compare a measurand associated with the biologicalsubject to a threshold value associated with a spectral model and togenerate a response based on the comparison. In an embodiment, thesystem 100 is configured to generate the response based on thecomparison of a measurand that modulates with a detected heart beat ofthe biological subject to a target value associated with a spectralmodel.

In an embodiment, the system 100 is configured to compare the measurandassociated with the biological subject to the threshold value associatedwith a spectral model and to generate a real-time estimation of aninfection state based on the comparison. In an embodiment, the system100 is configured to compare an input associated with at least onecharacteristic associated with, for example, a tissue proximate acatheter device 102 to a database 258 of stored reference values, and togenerate a response based in part on the comparison.

In an embodiment, the system 100 includes, among other things, one ormore data structures (e.g., physical data structures) 260. In anembodiment, a data structure 260 includes information associated with atleast one parameter associated with a tissue water content, anoxy-hemoglobin concentration, a deoxyhemoglobin concentration, anoxygenated hemoglobin absorption parameter, a deoxygenated hemoglobinabsorption parameter, a tissue light scattering parameter, a tissuelight absorption parameter, a hematological parameter, a pH level, orthe like. In an embodiment, the system 100 includes, among other things,at least one of inflammation indication parameter data, infectionindication parameter data, diseased tissue indication parameter data, orthe like configured as a data structure 260. In an embodiment, a datastructure 260 includes information associated with least one parameterassociated with a cytokine plasma concentration or an acute phaseprotein plasma concentration. In an embodiment, a data structure 260includes information associated with a disease state of a biologicalsubject. In an embodiment, a data structure 260 includes measurementdata. In an embodiment, the computing device 230 includes a processor232 configured to execute instructions, and a memory 250 that storesinstructions configured to cause the processor 232 to generate a secondresponse from information encoded in a data structure 260.

In an embodiment, the system 100 includes, among other things, one ormore computer-readable memory media (CRMM) 262 having biofilm markerinformation configured as a data structure 260. In an embodiment, thedata structure 260 includes a characteristic information section havingcharacteristic microbial colonization spectral informationrepresentative of the presence of a microbial colonization proximate atleast one of the outer surface 106 or the inner surface 108 of the bodystructure 104. In an embodiment, the data structure 260 includesinfection marker information. In an embodiment, the data structure 260includes biofilm marker information.

In an embodiment, the data structure 260 includes a characteristicinformation component including metabolite information associated with amicroorganism colonization event. In an embodiment, the data structure260 includes a characteristic information component including temporalmetabolite information or spatial metabolite information associated witha microorganism colonization event. In an embodiment, the data structure260 includes a characteristic information component including oxygenconcentration gradient information associated with a microorganismcolonization event. In an embodiment, the data structure 260 includes acharacteristic information component including pH information associatedwith a microorganism colonization event. In an embodiment, the datastructure 260 includes a characteristic information component includingnutrient information associated with a microorganism colonization event.In an embodiment, the data structure 260 includes a characteristicinformation component including spectral information associate with abiofilm-specific tag.

In an embodiment, the data structure 260 includes a characteristicinformation component including optical density information. In anembodiment, the data structure 260 includes a characteristic informationcomponent including opacity information. In an embodiment, the datastructure 260 includes a characteristic information component includingrefractivity information. In an embodiment, the data structure 260includes a characteristic information component including characteristicinfection marker spectral information. In an embodiment, the datastructure 260 includes a characteristic information component includingcharacteristic infective stress marker spectral information. In anembodiment, the data structure 260 includes a characteristic informationcomponent including characteristic sepsis maker spectral information.

In an embodiment, the data structure 260 includes at least one ofpsychosis state marker information, psychosis trait marker information,or psychosis indication information. In an embodiment, the datastructure 260 includes at least one of psychosis state indicationinformation, psychosis trait indication information, or predispositionfor a psychosis indication information. In an embodiment, the datastructure 260 includes at least one of infection indication information,inflammation indication information, diseased state indicationinformation, or diseased tissue indication information.

In an embodiment, a data structure 260 includes biological samplespectral information. In an embodiment, the data structure 260 includesone or more heuristically determined parameters associated with at leastone in vivo or in vitro determined metric. For example, informationassociated with a biological sample can be determined by one or more invivo or in vitro technologies or methodologies including, for example,remittance (reflectance, etc.) spectroscopy, high-resolution protonmagnetic resonance spectroscopy, nanoprobe nuclear magnetic resonancespectroscopy, in vivo micro-dialysis, flow cytometry, or the like.Non-limiting examples of heuristics include a heuristic protocol,heuristic algorithm, threshold information, a threshold level, a targetparameter, or the like. in an embodiment, the system 100 includes, amongother things, a means for generating one or more heuristicallydetermined parameters associated with at least one in vivo or in vitrodetermined metric including at least one computing device 230 and one ormore data structures 260 having heuristic modeling information. In anembodiment, the system 100 includes, among other things, a means forgenerating a response based on a comparison, of a detected at least oneof an emitted energy or a remitted energy to at least one heuristicallydetermined parameter, including at least one computing device 230, oneor more sensor components 502, or one or more data structures 260. In anembodiment, the system 100 includes, among other things, means forgenerating a response based on a comparison, of a detected at least oneof an emitted energy or a remitted energy to at least one heuristicallydetermined parameter, including one or more computing devices 230 andone or more data structures 260 configured with characteristicinformation.

In an embodiment, a data structure 260 includes one or more heuristics.In an embodiment, the one or more heuristics include a heuristic fordetermining a rate of change associated with at least one physicalparameter associated with a biological sample. For example, in anembodiment, the one or more heuristics include a heuristic fordetermining the presence of an infectious agent. In an embodiment, theone or more heuristics include a heuristic for determining at least onedimension of an infected tissue region. In an embodiment, the one ormore heuristics include a heuristic for determining a location of aninfection. In an embodiment, the one or more heuristics include aheuristic for determining a rate of change associated with a biochemicalmarker within the one or more fluid-flow passageways 110.

In an embodiment, the one or more heuristics include a heuristic fordetermining a biochemical marker aggregation rate. In an embodiment, theone or more heuristics include a heuristic for determining a type ofbiochemical marker. In an embodiment, the one or more heuristics includea heuristic for generating at least one initial parameter. In anembodiment, the one or more heuristics include a heuristic for formingan initial parameter set from one or more initial parameters. In anembodiment, the one or more heuristics include a heuristic forgenerating at least one initial parameter, and for forming an initialparameter set from the at least one initial parameter. In an embodiment,the one or more heuristics include at least one pattern classificationand regression protocol.

In an embodiment, a data structure 260 includes information associatedwith at least one parameter associated with a tissue water content, anoxy-hemoglobin concentration, a deoxyhemoglobin concentration, anoxygenated hemoglobin absorption parameter, a deoxygenated hemoglobinabsorption parameter, a tissue light scattering parameter, a tissuelight absorption parameter, a hematological parameter, a pH level, orthe like. In an embodiment, the system 100 includes, among other things,at least one of inflammation indication parameter data, infectionindication parameter data, diseased tissue indication parameter data, orthe like configured as a data structure 260. In an embodiment, a datastructure 260 includes information associated with least one parameterassociated with a cytokine plasma concentration or an acute phaseprotein plasma concentration. In an embodiment, a data structure 260includes information associated with a disease state of a biologicalsubject. In an embodiment, a data structure 260 includes measurementdata.

Referring to FIG. 5, in an embodiment, the system 100 includes, amongother things, one or more computer-readable media drives 264, interfacesockets, Universal Serial Bus (USB) ports, memory card slots, or thelike, or one or more input/output components 266 such as, for example, agraphical user interface 268, a display, a keyboard 270, a keypad, atrackball, a joystick, a touch-screen, a mouse, a switch, a dial, or thelike, and any other peripheral device. In an embodiment, the system 100includes one or more user input/output components 266 that operablycouple to at least one computing device 230 to control (electrical,electromechanical, software-implemented, firmware-implemented, or othercontrol, or combinations thereof) at least one parameter associated withthe energy delivery associated with one or more of the energy emitters220.

In an embodiment, the system 100 includes, among other things, one ormore modules optionally operable for communication with one or moreinput/output components 266 that are configured to relay user outputand/or input. In an embodiment, a module includes one or more instancesof electrical, electromechanical, software-implemented,firmware-implemented, or other control devices. Such devices include oneor more instances of memory 250, computing devices 230, ports, valves,fuses, antifuses, antennas, power, or other supplies; logic modules orother signaling modules; gauges or other such active or passivedetection components; or piezoelectric transducers, shape memoryelements, micro-electro-mechanical system (MEMS) elements, or otheractuators.

The computer-readable media drive 264 or memory slot can be configuredto accept signal-bearing medium (e.g., computer-readable memory media,computer-readable recording media, or the like). In an embodiment, aprogram for causing the system 100 to execute any of the disclosedmethods can be stored on, for example, a computer-readable recordingmedium (CRMM) 262, a signal-bearing medium, or the like. Non-limitingexamples of signal-bearing media include a recordable type medium suchas a magnetic tape, floppy disk, a hard disk drive, a Compact Disc (CD),a Digital Video Disk (DVD), Blu-Ray Disc, a digital tape, a computermemory, or the like, as well as transmission type medium such as adigital and/or an analog communication medium (e.g., a fiber opticcable, a waveguide, a wired communications link, a wirelesscommunication link (e.g., transmitter, receiver, transmission logic,reception logic, etc.), etc.). Further non-limiting examples ofsignal-bearing media include, but are not limited to, DVD-ROM, DVD-RAM,DVD+RW, DVD-RW, DVD-R, DVD+R, CD-ROM, Super Audio CD, CD-R, CD+R, CD+RW,CD-RW, Video Compact Discs, Super Video Discs, flash memory, magnetictape, magneto-optic disk, MINIDISC, non-volatile memory card, EEPROM,optical disk, optical storage, RAM, ROM, system memory, web server, orthe like.

In an embodiment, the system 100 includes signal-bearing media in theform of one or more logic devices (e.g., programmable logic devices,complex programmable logic device, field-programmable gate arrays,application specific integrated circuits, or the like) comprising, forexample, a data structure 260 including one or more look-up tables. Inan embodiment, the system 100 includes, among other things,signal-bearing media having sample information (e.g., biological sampleinformation, reference information, characteristic spectral information,or the like) configured as a data structure 260. In an embodiment, thedata structure 260 includes at least one of psychosis state indicationinformation, psychosis trait indication information, or predispositionfor a psychosis indication information. In an embodiment, the datastructure 260 includes at least one of infection indication information,inflammation indication information, diseased state indicationinformation, or diseased tissue indication information.

Referring to FIG. 5, in an embodiment, the system 100 includes, amongother things, at least one sensor component 502. In an embodiment, thecatheter device 102 includes at least one sensor component 502. In anembodiment, the sensor component 502 is configured to detect (e.g.,assess, calculate, evaluate, determine, gauge, measure, monitor,quantify, resolve, sense, or the like) at least one characteristic(e.g., a spectral characteristic, a spectral signature, a physicalquantity, a relative quantity, an environmental attribute, a physiologiccharacteristic, or the like) associated with a biological subject. In anembodiment, the sensor component 502 is configured to perform areal-time comparison of a measurand associated with a biological sampleproximate the catheter device 102 to stored reference data and togenerate a response based on the comparison.

In an embodiment, the sensor component 502 is operably coupled to one ormore computing device 230. In an embodiment, at least one computingdevice 230 is operably coupled to the sensor component 502 andconfigured to process an output associated with one or more sensormeasurands. In an embodiment, at least one computing devices 230 isconfigured to concurrently or sequentially operate multiple sensorcomponents 502. In an embodiment, the sensor component 502 includes acomputing device 230 configured to process sensor measurand informationand configured to cause the storing of the measurand information in adata storage medium. In an embodiment, the sensor component 502 includesa component identification code and is configured to implementinstructions addressed to the sensor component 502 according to thecomponent identification code.

In an embodiment, the sensor component 502 includes one or more surfaceplasmon resonance sensors. For example, in an embodiment, the sensorcomponent 502 includes one or more localized surface plasmon resonancesensors. In an embodiment, the sensor component 502 includes a lighttransmissive support and a reflective metal layer. In an embodiment, thesensor component 502 includes a wavelength-tunable surface plasmonresonance sensor. In an embodiment, the sensor component 502 includes asurface plasmon resonance microarray sensor having a wavelength-tunablemetal-coated grating. In an embodiment, the sensor component 502includes a surface plasmon resonance microarray sensor having an arrayof micro-regions configured to capture target molecules.

In an embodiment, the sensor component 502 includes one or moreelectrochemical transducers, optical transducers, piezoelectrictransducers, or thermal transducers. For example, in an embodiment, thesensor component 502 includes one or more transducers configured todetect acoustic waves associated with changes in a biological masspresent proximate a surface of the body structure 104.

In an embodiment, the sensor component 502 includes one or more thermaldetectors, photovoltaic detectors, or photomultiplier detectors. In anembodiment, the sensor component 502 includes one or more charge-coupleddevices, complementary metal-oxide-semiconductor devices, photodiodeimage sensor devices, whispering gallery mode micro cavity devices, orscintillation detector devices. In an embodiment, the sensor component502 includes one or more ultrasonic transducers. In an embodiment, thesensor component 502 includes at least one of a charge-coupled device, acomplementary metal-oxide-semiconductor device, a photodiode imagesensor device, a Whispering Gallery Mode (WGM) micro cavity device, anda scintillation detector device.

In an embodiment, the sensor component 502 includes at least one of animaging spectrometer, a photo-acoustic imaging spectrometer, athermo-acoustic imaging spectrometer, or aphoto-acoustic/thermo-acoustic tomographic imaging spectrometer. In anembodiment, the sensor component 502 includes at least one of a thermaldetector, a photovoltaic detector, or a photomultiplier detector.

In an embodiment, the sensor component 502 includes one or more densitysensors. In an embodiment, the sensor component 502 includes one or moreoptical density sensors. In an embodiment, the sensor component 502includes one or more refractive index sensors. In an embodiment, thesensor component 502 includes one or more fiber optic refractive indexsensors.

In an embodiment, the sensor component 502 includes one or more acousticbiosensors, amperometric biosensors, calorimetric biosensors, opticalbiosensors, or potentiometric biosensors. In an embodiment, the sensorcomponent 502 includes one or more fluid flow sensors. In an embodiment,the sensor component 502 includes one or more differential electrodes,biomass sensors, immunosensors, or the like. In an embodiment, thesensor component 502 includes one or more one-, two-, orthree-dimensional photodiode arrays.

In an embodiment, the sensor component 502 is operably coupled to amicroorganism colonization biomarker array. In an embodiment, the sensorcomponent 502 includes one or more functionalized cantilevers. In anembodiment, the sensor component 502 includes a biological moleculecapture layer. In an embodiment, the sensor component 502 includes abiological molecule capture layer having an array of different bindingmolecules that specifically bind one or more target molecules. In anembodiment, the sensor component 502 includes one or more computingdevices 230 operably coupled to one or more sensors. For example, in anembodiment, the sensor component 502 includes a computing device 230operably coupled to one or more surface plasmon resonance microarraysensors.

In an embodiment, the sensor component 502 is configured to detect atleast one characteristic associated with a biological subject. In anembodiment, the sensor component 502 is configured to detect at leastone characteristic associated with a biological specimen proximate asurface of the catheter device 102. For example, in an embodiment, thesensor component 502 is configured to detect at least one characteristicassociated with a tissue proximate the catheter device 102.

In an embodiment, the at least one characteristic includes at least oneof a transmittance, an energy frequency change, a frequency shift, anenergy phase change, or a phase shift. In an embodiment, the at leastone characteristic includes at least one of a fluorescence, an intrinsicfluorescence, a tissue fluorescence, or a naturally occurringfluorophore fluorescence. In an embodiment, the at least onecharacteristic includes at least one of an electrical conductivity,electrical polarizability, or an electrical permittivity. In anembodiment, the at least one characteristic includes at least one of athermal conductivity, a thermal diffusivity, a tissue temperature, or aregional temperature.

In an embodiment, the at least one characteristic includes at least oneparameter associated with a doppler optical coherence tomograph. (See,e.g., Li et al., Feasibility of Interstitial Doppler Optical CoherenceTomography for In vivo Detection of Microvascular Changes DuringPhotodynamic Therapy, Lasers in surgery and medicine 38 (8):754-61.(2006); see, also U.S. Pat. No. 7,365,859 (issued Apr. 29, 2008); eachof which is incorporated herein by reference.

In an embodiment, the at least one characteristic includes spectralsignature information associated with an implant device. For example, inan embodiment, the at least one characteristic includes implant devicespectral signature information associated with at least one of abio-implants, bioactive implants, breast implants, cochlear implants,dental implants, neural implants, orthopedic implants, ocular implants,prostheses, implantable electronic device, implantable medical devices,or the like. Further non-limiting examples of implant devices includereplacements implants (e.g., joint replacements implants, or the like),knee, shoulder, wrists replacements implants, or the like), subcutaneousdrug delivery devices (e.g., implantable pills, drug-eluting stents, orthe like), shunts (e.g., cardiac shunts, lumbo-peritoneal shunts,cerebrospinal fluid shunts, cerebral shunts, pulmonary shunts,portosystemic shunts, portacaval shunts, or the like), stents (e.g.,coronary stents, peripheral vascular stents, prostatic stents, ureteralstents, vascular stents, or the like), biological fluid flow controllingimplants, or the like. Further non-limiting examples of implant deviceinclude artificial hearts, artificial joints, artificial prosthetics,catheters, contact lens, mechanical heart valves, subcutaneous sensors,urinary catheters, vascular catheters, or the like.

In an embodiment, the at least one characteristic includes at least oneparameter associated with a medical state (e.g., medical condition,disease state, disease attributes, etc.). Inflammation is a complexbiological response to insults that can arise from, for example,chemical, traumatic, or infectious stimuli. It is a protective attemptby an organism to isolate and eradicate the injurious stimuli as well asto initiate the process of tissue repair. The events in the inflammatoryresponse are initiated by a complex series of interactions involvinginflammatory mediators, including those released by immune cells andother cells of the body. Histamines and eicosanoids, such asprostaglandins and leukotrienes, act on blood vessels at the site ofinfection to localize blood flow, concentrate plasma proteins, andincrease capillary permeability.

Chemotactic factors, including certain eicosanoids, complement, andespecially cytokines known as chemokines, attract particular leukocytesto the site of infection. Other inflammatory mediators, including somereleased by the summoned leukocytes, function locally and systemicallyto promote the inflammatory response. Platelet activating factors andrelated mediators function in clotting, which aids in localization andcan trap pathogens. Certain cytokines, interleukins and TNF, inducefurther trafficking and extravasation of immune cells, hematopoiesis,fever, and production of acute phase proteins. Once signaled, some cellsand/or their products directly affect the offending pathogens, forexample by inducing phagocytosis of bacteria or, as with interferon,providing antiviral effects by shutting down protein synthesis in thehost cells.

Oxygen radicals, cytotoxic factors, and growth factors can also bereleased to fight pathogen infection or to facilitate tissue healing.This cascade of biochemical events propagates and matures theinflammatory response, involving the local vascular system, the immunesystem, and various cells within the injured tissue. Under normalcircumstances, through a complex process of mediator-regulatedpro-inflammatory and anti-inflammatory signals, the inflammatoryresponse eventually resolves itself and subsides. For example, thetransient and localized swelling associated with a cut is an example ofan acute inflammatory response. However, in certain cases resolutiondoes not occur as expected. Prolonged inflammation, known as chronicinflammation, leads to a progressive shift in the type of cells presentat the site of inflammation and is characterized by simultaneousdestruction and healing of the tissue from the inflammatory process, asdirected by certain mediators. Rheumatoid arthritis is an example of adisease associated with persistent and chronic inflammation.

Non-limiting suitable techniques for optically measuring a diseasedstate may be found in, for example, U.S. Pat. No. 7,167,734 (issued Jan.23, 2007), which is incorporated herein by reference. In an embodiment,the at least one characteristic includes at least one of anelectromagnetic energy absorption parameter, an electromagnetic energyemission parameter, an electromagnetic energy scattering parameter, anelectromagnetic energy reflectance parameter, or an electromagneticenergy depolarization parameter. In an embodiment, the at least onecharacteristic includes at least one of an absorption coefficient, anextinction coefficient, or a scattering coefficient.

In an embodiment, the at least one characteristic includes at least oneparameter associated with an infection marker (e.g., an infectious agentmarker), an inflammation marker, an infective stress marker, a systemicinflammatory response syndrome marker, or a sepsis marker. Non-limitingexamples of infection makers, inflammation markers, or the like may befound in, for example, Imam et al., Radiotracers for imaging ofinfection and inflammation—A Review, World J. Nucl. Med. 40-55 (2006),which is incorporated herein by reference. Non-limiting characteristicsassociated with an infection marker, an inflammation marker, aninfective stress marker, a systemic inflammatory response syndromemarker, or a sepsis marker include at least one of an inflammationindication parameter, an infection indication parameter, a diseasedstate indication parameter, or a diseased tissue indication parameter.

In an embodiment, the response includes generating a visual, an audio, ahaptic, or a tactile representation of at least one spectral parameterassociated with a detected infection marker. In an embodiment, theresponse includes generating a visual, an audio, a haptic, or a tactilerepresentation of at least one physical parameter indicative of at leastone dimension of infected tissue region.

In an embodiment, the at least one characteristic includes at least oneof a tissue water content, an oxy-hemoglobin concentration, adeoxyhemoglobin concentration, an oxygenated hemoglobin absorptionparameter, a deoxygenated hemoglobin absorption parameter, a tissuelight scattering parameter, a tissue light absorption parameter, ahematological parameter, or a pH level.

In an embodiment, the at least one characteristic includes at least onehematological parameter. Non-limiting examples of hematologicalparameters include an albumin level, a blood urea level, a blood glucoselevel, a globulin level, a hemoglobin level, erythrocyte count, aleukocyte count, or the like. In an embodiment, the infection markerincludes at least one parameter associated with a red blood cell count,a lymphocyte level, a leukocyte count, a myeloid cell count, anerythrocyte sedimentation rate, or a C-reactive protein level. In anembodiment, the at least one characteristic includes at least oneparameter associated with a cytokine plasma level or an acute phaseprotein plasma level. In an embodiment, the at least one characteristicincludes at least one parameter associated with a leukocyte level.

In an embodiment, the at least one characteristic includes a spectralparameter associated with a biofilm-specific tag. In an embodiment, theat least one characteristic includes an optical density. In anembodiment, the at least one characteristic includes an opacity. In anembodiment, the at least one characteristic includes a refractivity. Inan embodiment, the at least one characteristic includes an absorbance,reflectance, or a transmittance. In an embodiment, the at least onecharacteristic includes at least one of an inflammation indicationparameter, an infection indication parameter, a diseased stateindication parameter, or a diseased tissue indication parameter. In anembodiment, the at least one characteristic includes at least one of anelectromagnetic energy absorption parameter, an electromagnetic energyemission parameter, an electromagnetic energy scattering parameter, anelectromagnetic energy reflectance parameter, or an electromagneticenergy depolarization parameter. In an embodiment, the at least onecharacteristic includes at least one an absorption coefficient, anextinction coefficient, a scattering coefficient, or a fluorescencecoefficient. In an embodiment, the at least one characteristic includesat least at least one of parameter associated with a biomarker, aninfection marker, an inflammation marker, an infective stress marker, ora sepsis marker.

In an embodiment, the at least one characteristic includes at least oneof an electromagnetic energy phase shift parameter, an electromagneticenergy dephasing parameter, or an electromagnetic energy depolarizationparameter. In an embodiment, the at least one characteristic associatedincludes at least one of an absorbance, a reflectivity, or atransmittance. In an embodiment, the at least one characteristicassociated includes at least one of a refraction or a scattering.

In an embodiment, the sensor component 502 is configured to determine atleast one characteristic associated with one or more biological markersor biological components (e.g., cerebrospinal fluid components, bloodcomponents, or the like). In an embodiment, the sensor component 502 isconfigured to determine at least one characteristic associated with atissue proximate the catheter device 102. In an embodiment, the sensorcomponent 502 is configured to determine a spatial dependence associatedwith the least one characteristic. In an embodiment, the sensorcomponent 502 is configured to determine a temporal dependenceassociated with the least one characteristic. In an embodiment, thesensor component 502 is configured to concurrently or sequentiallydetermine at least one spatial dependence associated with the least onecharacteristic and at least one temporal dependence associated with theleast one characteristic.

In an embodiment, the sensor component 502 is configured to determine atleast one spectral parameter associated with one or more imaging probes(e.g., chromophores, fluorescent agents, fluorescent marker,fluorophores, molecular imaging probes, quantum dots, or radio-frequencyidentification transponders (RFIDs), x-ray contrast agents, or thelike). In an embodiment, the sensor component 502 is configured todetermine at least one characteristic associated with one or moreimaging probes attached, targeted to, conjugated, bound, or associatedwith at least one inflammation markers. See, e.g., the followingdocuments: Jaffer et al., Arterioscler. Thromb. Vasc. Biol. 2002; 22;1929-1935 (2002); Kalchenko et al., J. of Biomed. Opt. 11 (5):50507(2006); each of which is incorporated herein by reference.

In an embodiment, the one or more imaging probes include at least onecarbocyanine dye label. In an embodiment, the sensor component 502 isconfigured to determine at least one characteristic associated with oneor more imaging probes attached, targeted to, conjugated, bound, orassociated with at least one biomarker or biological sample component.

In an embodiment, the one or more imaging probes include at least onefluorescent agent. In an embodiment, the one or more imaging probesinclude at least one quantum dot. In an embodiment, the one or moreimaging probes include at least one radio-frequency identificationtransponder. In an embodiment, the one or more imaging probes include atleast one x-ray contrast agent. In an embodiment, the one or moreimaging probes include at least one molecular imaging probe.

Further non-limiting examples of imaging probes include fluorescein(FITC), indocyanine green (ICG), and rhodamine B. Non-limiting examplesof other fluorescent dyes for use in fluorescence imaging include anumber of red and near infrared emitting fluorophores (600-1200 nm)including cyanine dyes such as Cy5, Cy5.5, and Cy7 (AmershamBiosciences, Piscataway, N.J., USA) or a variety of Alexa Fluor dyessuch as Alexa Fluor 633, Alexa Fluor 635, Alexa Fluor 647, Alexa Fluor660, Alexa Fluor 680, Alexa Fluor 700, Alexa Fluor 750 (MolecularProbes-Invitrogen, Carlsbad, Calif., USA; see, also, U.S. Patent Pub.No. 2005/0171434 (published Aug. 4, 2005) (each of which is incorporatedherein by reference), or the like.

Further non-limiting examples of imaging probes include IRDye800,IRDye700, and IRDye680 (LI-COR, Lincoln, Nebr., USA), NIR-1 and 1C5-OSu(Dejindo, Kumamotot, Japan), LaJolla Blue (Diatron, Miami, Fla., USA),FAR-Blue, FAR-Green One, and FAR-Green Two (Innosense, Giacosa, Italy),ADS 790-NS, ADS 821-NS (American Dye Source, Montreal, CA), NIAD-4 (ICxTechnologies, Arlington, Va.), or the like. Further non-limitingexamples of fluorophores include BODIPY-FL, europium, green, yellow andred fluorescent proteins, luciferase, or the like. Quantum dots ofvarious emission/excitation properties can be used as imaging probes.See, e.g., Jaiswal, et al. Nature Biotech. 21:47-51 (2003) (which isincorporated herein by reference). Further non-limiting examples ofimaging probes include those including antibodies specific forleukocytes, anti-fibrin antibodies, monoclonal anti-diethylene triaminepentaacetic acid (DTPA), DTPA labeled with Technetium-99m (^(99m)TC), orthe like.

Further non-limiting examples of biomarkers include high-sensitivityC-reactive protein (hs-CRP), cardiac troponin T (cTnT), cardiac troponinI (cTnI), N-terminal-pro B-type natriuretic peptide (NT-proBNP),D-dimer, P-selectin, E-selectin, thrombin, interleukin-10, fibrinmonomers, phospholipid microparticles, creatine kinase, interleukin-6,tumor necrosis factor-alpha, myeloperoxidase, intracellular adhesionmolecule-1 (ICAM1), vascular adhesion molecule (VCAM), matrixmetalloproteinase-9 (MMP9), ischemia modified albumin (IMA), free fattyacids, choline, soluble CD40 ligand, insulin-like growth factor, (see,e.g., Giannitsis, et al. Risk stratification in pulmonary embolism basedon biomarkers and echocardiography. Circ. 112:1520-1521 (2005), Barnes,et al., Novel biomarkers associated with deep venous throbosis: Acomprehensive review. Biomarker Insights 2:93-100 (2007); Kamphuisen,Can anticoagulant treatment be tailored with biomarkers in patients withvenous thromboembolism? J. Throm. Haemost. 4:1206-1207 (2006); Rosalki,et al., Cardiac biomarkers for detection of myocardial infarction:Perspectives from past to present. Clin. Chem. 50:2205-2212 (2004);Apple, et al., Future biomarkers for detection of ischemia and riskstratification in acute coronary syndrome, Clin. Chem. 51:810-824(2005); each of which is incorporated herein by reference.

In an embodiment, the sensor component 502 is configured to detect aspectral response (e.g., an emitted energy, a remitted energy, an energyabsorption profile, energy emission profile, or the like) associatedwith a biomarker. Among biomarker examples include, but are not limitedto, one or more substances that are measurable indicators of abiological state and can be used as indicators of normal disease state,pathological disease state, and/or risk of progressing to a pathologicaldisease state. In some instances, a biomarker can be a normal bloodcomponent that is increased or decreased in the pathological state. Abiomarker can also be a substance that is not normally detected inbiological sample, fluid, or tissue, but is released into circulationbecause of the pathological state. In some instances, a biomarker can beused to predict the risk of developing a pathological state. Forexample, plasma measurement of lipoprotein-associated phospholipase A2(Lp-PLA2) is approved by the U.S. Food & Drug Administration (FDA) forpredicting the risk of first time stroke.

In other instances, the biomarker can be used to diagnose an acutepathological state. For example, elevated plasma levels of S-100b,B-type neurotrophic growth factor (BNGF), von Willebrand factor (vWF),matrix metalloproteinase-9 (MMP-9), and monocyte chemoattractantprotein-1 (MCP-1) are highly correlated with the diagnosis of stroke(see, e.g., Reynolds, et al., Early biomarkers of stroke. Clin. Chem.49:1733-1739 (2003), which is incorporated herein by reference).

In an embodiment, the sensor component 502 is configured to detect atleast one characteristic associated with one or more biological samplecomponents. In an embodiment, the at least one characteristic includesat least one of absorption coefficient information, extinctioncoefficient information, or scattering coefficient informationassociated with the at least one molecular probe. In an embodiment, theat least one characteristic includes spectral information indicative ofa rate of change, an accumulation rate, an aggregation rate, or a rateof change associated with at least one physical parameter associatedwith a biological sample component.

In an embodiment, the sensor component 502 is configured to detectspectral information associated with a real-time change in one or moreparameters associated with a biological sample. For example, in anembodiment, the sensor component 502 is configured to detect at leastone of an emitted energy or a remitted energy associated with areal-time change in one or more parameters associated with a biologicalsample within one or more regions in the immediate vicinity of acatheter device 102. In an embodiment, the sensor component 502 includesone or more transducers 223 a configured to detect sound wavesassociated with changes in a biological sample present proximate atleast one of the outer surface and the inner surface of the bodystructure.

In an embodiment, the sensor component 502 is configured to detect atleast one of an emitted energy or a remitted energy. In an embodiment,the sensor component 502 is configured to detect at least one of anemitted energy or a remitted energy associated with a biologicalsubject. In an embodiment, the sensor component 502 is configured todetect an optical energy absorption profile of a target sample, aportion of a tissue, or portion of a biological sample within thebiological subject. In an embodiment, the sensor component 502 isconfigured to detect an excitation radiation and an emission radiationassociated with a portion of a target sample, a portion of a tissue, orportion of a biological sample within the biological subject. In anembodiment, the sensor component 502 is configured to detect at leastone of an energy absorption profile and an energy reflection profile ofa region within a biological subject.

In an embodiment, the sensor component 502 is configured to detect aspectral response from tissue of a biological subject. Blood is a tissuecomposed of, among other components, formed elements (e.g., blood cellssuch as erythrocytes, leukocytes, thrombocytes, or the like) suspend ina matrix (plasma). The heart, blood vessels (e.g., arteries, arterioles,capillaries, veins, venules, or the like), and blood components, make upthe cardiovascular system. The cardiovascular system, among otherthings, moves oxygen, gases, and wastes to and from cells and tissues,maintains homeostasis by stabilizing body temperature and pH, and helpsfight diseases.

In an embodiment, the sensor component 502 is configured to detect atleast one of an emitted energy or a remitted energy associated with aportion of a cardiovascular system. In an embodiment, the sensorcomponent 502 is configured to detect at least one of an emitted energyand a remitted energy associated with one or more blood componentswithin a biological subject. In an embodiment, the sensor component 502is configured to detect at least one of an emitted energy or a remittedenergy associated with one or more formed elements within a biologicalsubject. In an embodiment, the sensor component 502 is configured todetect spectral information associated with one or more bloodcomponents. In an embodiment, the sensor component 502 is configured todetect at least one of an emitted energy or a remitted energy associatedwith a real-time change in one or more parameters associated with atleast one blood component within a biological subject. In an embodiment,the sensor component 502 is configured to detect an energy absorption ofone or more blood components.

Non-limiting examples of detectable blood components includeerythrocytes, leukocytes (e.g., basophils, granulocytes, eosinophils,monocytes, macrophages, lymphocytes, neutrophils, or the like),thrombocytes, acetoacetate, acetone, acetylcholine, adenosinetriphosphate, adrenocorticotrophic hormone, alanine, albumin,aldosterone, aluminum, amyloid proteins (non-immunoglobulin),antibodies, apolipoproteins, ascorbic acid, aspartic acid, bicarbonate,bile acids, bilirubin, biotin, blood urea Nitrogen, bradykinin, bromide,cadmium, calciferol, calcitonin (ct), calcium, carbon dioxide,carboxyhemoglobin (as HbcO), cell-related plasma proteins,cholecystokinin (pancreozymin), cholesterol, citric acid, citrulline,complement components, coagulation factors, coagulation proteins,complement components, c-peptide, c-reactive protein, creatine,creatinine, cyanide, 11-deoxycortisol, deoxyribonucleic acid,dihydrotestosterone, diphosphoglycerate (phosphate), or the like.

Further non-limiting examples of detectable blood components includedopamine, enzymes, epidermal growth factor, epinephrine, ergothioneine,erythrocytes, erythropoietin, folic acid, fructose, furosemideglucuronide, galactoglycoprotein, galactose (children), gamma-globulin,gastric inhibitory peptide, gastrin, globulin, α-1-globulin,α-2-globulin, α-globulins, β-globulins, glucagon, glucosamine, glucose,immunoglobulins (antibodies), lipase p, lipids, lipoprotein (sr 12-20),lithium, low-molecular weight proteins, lysine, lysozyme (muramidase),α-2-macroglobulin, γ-mobility (non-immunoglobulin), pancreaticpolypeptide, pantothenic acid, para-aminobenzoic acid, parathyroidhormone, pentose, phosphorated, phenol, phenylalanine, phosphatase,acid, prostatic, phospholipid, phosphorus, prealbumin,thyroxine-binding, proinsulin, prolactin (female), prolactin (male),proline, prostaglandins, prostate specific antigen, protein,protoporphyrin, pseudoglobulin I, pseudoglobulin II, purine, pyridoxine,pyrimidine nucleotide, pyruvic acid, CCL5 (RANTES), relaxin, retinol,retinol-binding protein, riboflavin, ribonucleic acid, secretin, serine,serotonin (5-hydroxytryptamine), silicon, sodium, solids, somatotropin(growth hormone), sphingomyelin, succinic acid, sugar, sulfates,inorganic, sulfur, taurine, testosterone (female), testosterone (male),triglycerides, triiodothyronine, tryptophan, tyrosine, urea, uric acid,water, miscellaneous trace components, or the like.

Non-limiting examples of α-Globulins examples include α1-acidglycoprotein, α1-antichymotrypsin, α1-antitrypsin, α1B-glycoprotein,α1-fetoprotein, α1-microglobulin, α1T-glycoprotein, α2HS-glycoprotein,α2-macroglobulin, 3.1 S Leucine-rich α2-glycoprotein, 3.8 Shistidine-rich α2-glycoprotein, 4 S α2, α1-glycoprotein, 8 Sα3-glycoprotein, 9.5 S α1-glycoprotein (serum amyloid P protein),Corticosteroid-binding globulin, ceruloplasmin, GC globulin, haptoglobin(e.g., Type 1-1, Type 2-1, or Type 2-2), inter-α-trypsin inhibitor,pregnancy-associated α2-glycoprotein, serum cholinesterase,thyroxine-binding globulin, transcortin, vitamin D-binding protein,Zn-α2-glycoprotein, or the like. Among β-globulins, examples include,but are not limited to, hemopexin, transferrin, β2-microglobulin,β2-glycoprotein I, β2-glycoprotein II, (C3 proactivator),β2-glycoprotein III, C-reactive protein, fibronectin, pregnancy-specificβ1-glycoprotein, ovotransferrin, or the like. Among immunoglobulinsexamples include, but are not limited to, immunoglobulin G (e.g., IgG,IgG₁, IgG₂, IgG₃, IgG₄), immunoglobulin A (e.g., IgA, IgA₁, IgA₂),immunoglobulin M, immunoglobulin D, immunoglobulin E, κ Bence Jonesprotein, γ Bence Jones protein, J Chain, or the like.

Among apolipoproteins examples include, but are not limited to,apolipoprotein A-I (HDL), apolipoprotein A-II (HDL), apolipoprotein C-I(VLDL), apolipoprotein C-II, apolipoprotein C-III (VLDL), apolipoproteinE, or the like. Among γ-mobility (non-immunoglobulin) examples include,but are not limited to, 0.6 S γ2-globulin, 2 S γ2-globulin, basicProtein B2, post-γ-globulin (γ-trace), or the like. Among low-molecularweight proteins examples include, but are not limited to, lysozyme,basic protein B1, basic protein B2, 0.6 S γ2-globulin, 2 S γ 2-globulin,post γ-globulin, or the like.

Among complement components examples include, but are not limited to, C1esterase inhibitor, C1q component, C1r component, C1s component, C2component, C3 component, C3a component, C3b-inactivator, C4 bindingprotein, C4 component, C4a component, C4-binding protein, C5 component,C5a component, C6 component, C7 component, C8 component, C9 component,factor B, factor B (C3 proactivator), factor D, factor D (C3proactivator convertase), factor H, factor H (β₁H), properdin, or thelike. Among coagulation proteins examples include, but are not limitedto, antithrombin III, prothrombin, antihemophilic factor (factor VIII),plasminogen, fibrin-stabilizing factor (factor XIII), fibrinogen,thrombin, or the like.

Among cell-Related Plasma Proteins examples include, but are not limitedto, fibronectin, β-thromboglobulin, platelet factor-4, serum BasicProtease Inhibitor, or the like. Among amyloid proteins(Non-Immunoglobulin) examples include, but are not limited to,amyloid-Related apoprotein (apoSAA1), AA (FMF) (ASF), AA (TH) (AS),serum amyloid P component (9.5 S 7α1-glycoprotein), or the like. Amongmiscellaneous trace components examples include, but are not limited to,varcinoembryonic antigen, angiotensinogen, or the like.

In an embodiment, the sensor component 502 is configured to detect aspectral response associated with a real-time change in one or moreparameters associated with at least one biological sample component(e.g., a cerebrospinal fluid component). Non-limiting examples ofdetectable cerebrospinal fluid components include adenosine deaminase,albumin, calcium, chloride, C-reactive protein, creatine kinase,creatinine, cystatin C, cytokines, glucose, hydrogencarbonate,immunoglobulin G, interleukins, lactate, lactate dehydrogenase, lipids,lymphocytes, monocytes, mononuclear cells, myelin basic protein,neuron-specific enolase, potassium, proteins, S-100 protein, smallmolecules, sodium, β₂-microglobulin, or the like.

In an embodiment, the sensor component 502 is in optical communicationalong an optical path with at least one of the one or more energyemitters 220. In an embodiment, one or more of the energy emitters 220are configured to direct an in vivo generated pulsed energy stimulusalong an optical path for a duration sufficient to interact with one ormore regions within the biological subject and for a duration sufficientfor a portion of the in vivo generated pulsed energy stimulus to reach aportion of the sensor component 502 that is in optical communicationalong the optical path. In an embodiment, one or more of the energyemitters 220 are configured to direct optical energy along an opticalpath for a duration sufficient to interact with one or more regionswithin the biological subject and with at least a portion of the opticalenergy sensor component 502. In an embodiment, one or more of the energyemitters 220 are configured to emit a pulsed optical energy stimulusalong an optical path for a duration sufficient to interact with asample received within the one or more fluid-flow passageways 110, suchthat a portion of the pulsed optical energy stimulus is directed to aportion of the sensor component 502 that is in optical communicationalong the optical path.

In an embodiment, the system 100 includes one or more sensors 504. In anembodiment, the catheter device 102 includes one or more of the sensors504. In an embodiment, the sensor component 502 includes one or moresensors 504.

Non-limiting examples of sensors 504 include acoustic wave sensors,aptamer-based sensors, biosensors, blood volume pulse sensors,cantilevers, conductance sensors, electrochemical sensors, fluorescencesensors, force sensors, heat sensors (e.g., thermistors, thermocouples,or the like), high resolution temperature sensors, differentialcalorimeter sensors, optical sensors, goniometry sensors, potentiometersensors, resistance sensors, respiration sensors, sound sensors (e.g.,ultrasound), Surface Plasmon Band Gap sensor (SPRBG), physiologicalsensors, surface plasmon sensors, or the like. Further non-limitingexamples of sensors 504 include affinity sensors, bioprobes,biostatistics sensors, enzymatic sensors, in-situ sensors (e.g., in-situchemical sensor), ion sensors, light sensors (e.g., visible, infrared,or the like), microbiological sensors, microhotplate sensors,micron-scale moisture sensors, nanosensors, optical chemical sensors,single particle sensors, or the like.

Further non-limiting examples of sensors 504 include chemical sensors,cavitand-based supramolecular sensors, nucleic acid sensors,deoxyribonucleic acid sensors (e.g., electrochemical DNA sensors, or thelike), supramolecular sensors, or the like. In an embodiment, at leastone of the one or more sensors 504 is configured to detect or measurethe presence or concentration of specific target chemicals (e.g., bloodcomponents, biological sample component, cerebral spinal fluidcomponent, infectious agents, infection indication chemicals,inflammation indication chemicals, diseased tissue indication chemicals,biological agents, molecules, ions, or the like).

Further non-limiting examples of sensors 504 include chemicaltransducers, ion sensitive field effect transistors (ISFETs), ISFET pHsensors, membrane-ISFET devices (MEMFET), microelectronic ion-sensitivedevices, potentiometric ion sensors, quadruple-function ChemFET(chemical-sensitive field-effect transistor) integrated-circuit sensors,sensors with ion-sensitivity and selectivity to different ionic species,or the like. Further non-limiting examples of the one or more sensors504 can be found in the following documents (each of which isincorporated herein by reference): U.S. Pat. No. 7,396,676 (issued Jul.8, 2008) and U.S. Pat. No. 6,831,748 (issued Dec. 14, 2004); each ofwhich is incorporated herein by reference.

In an embodiment, the one or more sensors 504 include one or moreacoustic transducers, electrochemical transducers, photochemicaltransducer, optical transducers, piezoelectrical transducers, or thermaltransducers. For example, in an embodiment, the one or more sensors 504include one or more acoustic transducers. In an embodiment, the one ormore sensors 504 include one or more thermal detectors, photovoltaicdetectors, or photomultiplier detectors. In an embodiment, the one ormore sensors 504 include one or more charge coupled devices,complementary metal-oxide-semiconductor devices, photodiode image sensordevices, whispering gallery mode micro cavity devices, or scintillationdetector devices. In an embodiment, the one or more sensors 504 includeone or more complementary metal-oxide-semiconductor image sensors.

In an embodiment, the one or more sensors 504 include one or moreconductivity sensor. In an embodiment, the one or more sensors 504include one or more spectrometers. In an embodiment, the one or moresensors include one or more Bayer sensors. In an embodiment, the one ormore sensors include one or more Foveon sensors. In an embodiment, theone or more sensors 504 include one or more density sensors. In anembodiment, the one or more density sensors include one or more opticaldensity sensors. In an embodiment, the one or more density sensorsinclude one or more refractive index sensors. In an embodiment, the oneor more refractive index sensors include one or more fiber opticrefractive index sensors.

In an embodiment, the one or more sensors 504 include one or moresurface plasmon resonance sensors. In an embodiment, the one or moresensors 504 are configured to detect target molecules. For example,surface-plasmon-resonance-based-sensors detect target moleculessuspended in a fluid, for example, by reflecting light off thin metalfilms in contact with the fluid. Adsorbing molecules cause changes inthe local index of refraction, resulting in detectable changes in theresonance conditions of the surface plasmon waves.

In an embodiment, the one or more sensors 504 include one or morelocalized surface plasmon resonance sensors. In an embodiment, detectionof target molecules includes monitoring shifts in the resonanceconditions of the surface plasmon waves due to changes in the localindex of refraction associates with adsorption of target molecules. Inan embodiment, the one or more sensors 504 include one or morefunctionalized cantilevers. In an embodiment, the one or more sensors504 include a light transmissive support and a reflective metal layer.In an embodiment, the one or more sensors 504 include a biologicalmolecule capture layer. In an embodiment, the biological moleculecapture layer includes an array of different binding molecules thatspecifically bind one or more target molecules. In an embodiment, theone or more sensors 504 include a surface plasmon resonance microarraysensor having an array of micro-regions configured to capture targetmolecules.

In an embodiment, the one or more sensors 504 include one or moreacoustic biosensors, amperometric biosensors, calorimetric biosensors,optical biosensors, or potentiometric biosensors. In an embodiment, theone or more sensors 504 include one or more fluid flow sensors. In anembodiment, the one or more sensors 504 include one or more differentialelectrodes. In an embodiment, the one or more sensors 504 include one ormore biomass sensors. In an embodiment, the one or more sensors 504include one or more immunosensors.

In an embodiment, one or more of the sensors 504 are configured todetect at least one characteristic associated with a biological subject.In an embodiment, one or more of the sensors 504 are configured todetect at least one characteristic associated with a biological sample(e.g., tissue, biological fluid, target sample, or the like). Forexample, in an embodiment, at least one of the one or more sensors 504is configured to detect at least one characteristic associated with abiological sample proximate a surface (e.g., outer surface 108 or innersurface 110, or the like) of the catheter device 102. In an embodiment,one or more of the sensors 504 are configured to detect at least one ofa characteristic of a biological sample proximate the catheter device102, a characteristic of a tissue proximate the catheter device 102, anda physiological characteristic of the biological subject. In anembodiment, one or more of the sensors 504 are configured to determineone or more tissue spectroscopic properties, such as, for example, atransport scattering coefficient, an extinction coefficient, anabsorption coefficient, a remittance, a transmittance, or the like.

In an embodiment, the at least one characteristic includes aphysiological characteristic of the biological subject. Physiologicalcharacteristics such as, for example pH can be used to assess bloodflow, a cell metabolic state (e.g., anaerobic metabolism, or the like),the presence of an infectious agent, a disease state, or the like. Amongphysiological characteristics examples include, but are not limited to,at least one of a temperature, a regional or local temperature, a pH, animpedance, a density, a sodium ion level, a calcium ion level, apotassium ion level, a glucose level, a lipoprotein level, a cholesterollevel, a triglyceride level, a hormone level, a blood oxygen level, apulse rate, a blood pressure, an intracranial pressure, a respiratoryrate, a vital statistic, or the like.

In an embodiment, the at least one characteristic includes at least oneof a temperature, a pH, an impedance, a density, a sodium ion level, acalcium ion level, a potassium ion level, a glucose level, a lipoproteinlevel, a cholesterol level, a triglyceride level, a hormone level, ablood oxygen level, a pulse rate, a blood pressure, an intracranialpressure, or a respiratory rate. In an embodiment, the at least onecharacteristic includes at least one hematological parameter. In anembodiment, the hematological parameter is associated with ahematological abnormality.

In an embodiment, the at least one characteristic includes one or moreparameters associated with at least one of leukopenia, leukophilia,lymphocytopenia, lymphocytophilia, neutropenia, neutrophilia,thrombocytopenia, disseminated intravascular coagulation, bacteremia,and viremia. In an embodiment, the at least one characteristic includesat least one of an infection marker, an inflammation marker, aninfective stress marker, a systemic inflammatory response syndromemarker, or a sepsis marker. In an embodiment, the infection markerincludes at least one of a red blood cell count, a lymphocyte level, aleukocyte count, a myeloid count, an erythrocyte sedimentation rate, ora C-reactive protein level. In an embodiment, the at least onecharacteristic includes at least one of a cytokine plasma concentrationor an acute phase protein plasma concentration.

In an embodiment, the at least one characteristic includes acharacteristic associated with tissue proximate the catheter device 102.In an embodiment, the at least one characteristic includes acharacteristic associated with a biological sample. In an embodiment,the at least one characteristic includes a characteristic of a specimenof the biological subject. In an embodiment, the at least onecharacteristic includes one or more spectroscopic properties (e.g.,tissue spectroscopic properties, biological fluid spectroscopicproperties, infectious agent spectroscopic properties, biomarkerspectroscopic properties, or the like). In an embodiment, the at leastone characteristic includes at least one characteristic (e.g., aspectral characteristic, a spectral signature, a physical quantity, arelative quantity, an environmental attribute, a physiologiccharacteristic, or the like) associated with a region within thebiological subject. In an embodiment, the at least one characteristicincludes a characteristic associated with a fluid-flow passageway 110obstruction, a hematological abnormality, or a body fluid flowabnormality (e.g., a cerebrospinal fluid abnormality).

In an embodiment, the at least one characteristic includes acharacteristic associated with a biological fluid flow vessel. In anembodiment, the at least one characteristic includes a characteristicassociated with one or more biological sample components. In anembodiment, the at least one characteristic includes a characteristicassociated with one or more imaging probes attached, targeted to,conjugated, bound, or associated with at least one inflammation markers.In an embodiment, the at least one characteristic includes acharacteristic associated with one or more imaging probes attached,targeted to, conjugated, bound, or associated with at least one bloodcomponents. In an embodiment, the at least one characteristic includes acharacteristic associated with one or more blood components.

In an embodiment, the at least one characteristic includes at least oneparameter associated with an amount of energy-activatable disinfectingagent present in at least a portion of the tissue proximate a surface ofthe catheter device 102. In an embodiment, the at least onecharacteristic includes at least one of a sodium ion content, a chloridecontent, a superoxide anion content, or a hydrogen peroxide content. Inan embodiment, the at least one characteristic includes at least oneparameter associated with a tissue water content, an oxy-hemoglobinconcentration, a deoxyhemoglobin concentration, an oxygenated hemoglobinabsorption parameter, a deoxygenated hemoglobin absorption parameter, atissue light scattering parameter, a tissue light absorption parameter,a hematological parameter, or a pH level. In an embodiment, the at leastone characteristic includes at least one parameter associated with acytokine plasma concentration or an acute phase protein plasmaconcentration. In an embodiment, the at least one characteristicincludes at least one parameter associated with a leukocyte level.

In an embodiment, the at least one characteristic includes at least oneof a transmittance, an energy stimulus frequency change, energy stimulusfrequency shift, an energy stimulus phase change, and energy stimulusphase shift. In an embodiment; the at least one characteristic includesat least one of a fluorescence, an intrinsic fluorescence, a tissuefluorescence, or a naturally occurring fluorophore fluorescence. In anembodiment, the at least one characteristic includes at least one of anelectrical conductivity, electrical polarizability, or an electricalpermittivity. In an embodiment, the at least one characteristic includesat least one of a thermal conductivity, a thermal diffusivity, a tissuetemperature, or a regional temperature.

In an embodiment, the at least one characteristic includes a spectralparameter associated with a biofilm-specific tag. In an embodiment, theat least one characteristic includes an optical density. In anembodiment, the at least one characteristic includes an opacity. In anembodiment, the at least one characteristic includes a refractivity. Inan embodiment, the at least one characteristic includes an absorbance,reflectance, or a transmittance.

In an embodiment, the at least one characteristic includes at least oneof an inflammation indication parameter (e.g., an absence, a presence,or a severity indication parameter), an infection indication parameter,a diseased state indication parameter, or a diseased tissue indicationparameter. In an embodiment, the at least one characteristic includes atleast one of an electromagnetic energy absorption parameter, anelectromagnetic energy emission parameter, an electromagnetic energyscattering parameter, an electromagnetic energy reflectance parameter,or an electromagnetic energy depolarization parameter. In an embodiment,the at least one characteristic includes at least one an absorptioncoefficient, an extinction coefficient, a scattering coefficient, or afluorescence coefficient. In an embodiment, the at least onecharacteristic includes at least at least one of parameter associatedwith a biomarker, an infection marker, an inflammation marker, aninfective stress marker, or a sepsis marker.

In an embodiment, the at least one characteristic includes at least oneof a psychotic disorder indication parameter, a psychotic stateindication parameter, a psychotic trait indication parameter, apsychosis indication parameter, or a predisposition for a psychosisindication parameter. In an embodiment, the at least one characteristicincludes at least one of a psychotic disorder indication, psychoticstate indication, a psychotic trait indication, a psychosis indication,or a predisposition for a psychosis indication.

In an embodiment, one or more of the sensors 504 are configured todetect a microbial presence proximate the body structure 104 of thecatheter device 102. For example, in an embodiment, one or more of thesensors 504 are configured to detect absorbance, reflectance, or atransmittance spectra of one or more components indicative of amicrobial presence in one or more regions proximate at least one of theouter surface 106, the inner surface 108, or within at least one of theone or more fluid-flow passageways 110 of the body structure 104.

In an embodiment, one or more of the sensors 504 are configured todetect spectral information associated with a biological sample in thevicinity of the catheter device 102. For example, in an embodiment, oneor more of the sensors 504 are configured to detect at least one of anabsorption coefficient, an extinction coefficient, or a scatteringcoefficient associated with the biological sample.

In an embodiment, one or more of the sensors 504 are configured todetect spectral information associated with a microbial presence. Forexample, in an embodiment, at least one of the one or more sensors 504is configured to detect at least one of an emitted optical energy, aremitted optical energy, or an acoustic energy from a one or moreregions proximate at least one of the outer surface 106, the innersurface 108, and within at least one of the one or more fluid-flowpassageways 110 of the body structure 104, and to generate a firstresponse based on a detected at least one of an emitted optical energy,a remitted optical energy, or an acoustic energy. In an embodiment, atleast one of the one or more sensors 504 is configured to detect afluorescence associated with an autofluorescent material of biologicalsample proximate the body structure 104.

In an embodiment, one or more of the sensors 504 are configured todetect a change in at least one of a phase, a polarization, or arefraction associated with a microbial presence. In an embodiment, oneor more of the sensors 504 are configured to detect a microbial presencewithin the one or more fluid-flow passageways 110 based on one or moreflow characteristics. In an embodiment, one or more of the sensors 504are configured to detect a location associated with a microbialpresence. In an embodiment, one or more of the sensors 504 areconfigured to detect spectral information associated with at least oneof temporal metabolite information or spatial metabolite informationassociated with a microbial presence.

In an embodiment, the system 100 includes one or more computing devices230 operably coupled to one or more sensors 504. In an embodiment, atleast one computing device 230 is configured to process an outputassociated with one or more sensors 504. In an embodiment, the system100 includes one or more computing devices 230 configured toconcurrently or sequentially operate multiple sensors 504. In anembodiment, the system 100 is configured to compare an input associatedwith at least one characteristic associated with a tissue proximate acatheter device 102 to a data structure 260 including reference values,and to generate a response based in part on the comparison. In anembodiment, the system 100 is configured to compare an input associatedwith at least one physiological characteristic associated with abiological subject to a data structure 260 including reference values,and to generate a response based in part on the comparison. In anembodiment, the system 100 is configured to compare an input associatedwith at least one characteristic associated with a tissue proximate acatheter device 102 to a data structure 260 including reference values,and to generate a response based in part on the comparison.

In an embodiment, at least one computing device 230 is configured toperform a comparison of at least one detected characteristic to storedreference data, and to generate a response based at least in part on thecomparison. For example, in an embodiment, at least one computing device230 is configured to perform a comparison of at least one characteristicassociated with the biological sample to stored reference data, and toinitiate a treatment protocol based at least in part on the comparison.In an embodiment, at least one computing device 230 is configured toperform a comparison of a detected at least one of the emitted opticalenergy or the remitted optical energy from the region proximate the bodystructure 104 to reference spectral information, and to cause anemission of an energy stimulus from one or more energy emitters 220 toat least one of the outer surface 106 or the inner surface 108 of thebody structure 104. In an embodiment, one or more computing devices 230are communicatively coupled to one or more sensors 504 and configured toactuate a determination of the at least one characteristic associatedwith a biological specimen proximate a surface of the catheter device102.

In an embodiment, a computing device 230 is configured to compare ameasurand associated with the biological subject to a threshold valueassociated with a tissue spectral model and to generate a response basedon the comparison. In an embodiment, a computing device 230 isconfigured to generate the response based on the comparison of ameasurand that modulates with a detected heart beat of the biologicalsubject to a target value associated with a tissue spectral model. In anembodiment, a computing device 230 is configured to concurrently orsequentially operate multiple energy emitters 220. In an embodiment, acomputing device 230 is configured to compare an input associated withat least one characteristic associated with, for example, a tissueproximate a catheter device 102 to a database 258 of stored referencevalues, and to generate a response based in part on the comparison.

In an embodiment, the response includes, among other things, at leastone of a response signal, an absorption parameter, an extinctionparameter, a scattering parameter, a comparison code, a comparison plot,a diagnostic code, a treatment code, an alarm response, or a test codebased on the comparison of a detected optical energy absorption profileto characteristic spectral signature information. In an embodiment, theresponse includes at least one of a display, a visual representation(e.g., a visual depiction representative of the detected (e.g.,assessed, calculated, evaluated, determined, gauged, measured,monitored, quantified, resolved, sensed, or the like) information)component, a visual display of at least one spectral parameter, or thelike. In an embodiment, the response includes a visual representationindicative of a parameter associated with an infection present in aregion of a tissue proximate one or more sensors 504. In an embodiment,the response includes generating a representation (e.g., depiction,rendering, modeling, or the like) of at least one physical parameterassociated with a biological specimen.

In an embodiment, the response includes generating at least one of avisual, an audio, a haptic, or a tactile representation of at least oneof spectral component associated with a biofilm marker. In anembodiment, the response includes at least one of activating anauthorization protocol, activating an authentication protocol,activating a software update protocol, activating a data transferprotocol, or activating a biofilm sterilization diagnostic protocol.

In an embodiment, the response includes one or more of a responsesignal, a control signal, a change to an energy stimulus parameter, achange in an excitation intensity, a change in an excitation frequency,a change in an excitation pulse frequency, a change in an excitationpulse ratio, a change in an excitation pulse intensity, a change in anexcitation pulse duration time, a change in an excitation pulserepetition rate, or a change in an energy stimulus delivery regimenparameter. In an embodiment, the response includes one or more ofsending information associated with at least one of an authenticationprotocol, an authorization protocol, an energy stimulus deliveryprotocol, an activation protocol, an encryption protocol, or adecryption protocol.

In an embodiment, at least one computing device 230 is configured toperform a comparison of the at least one characteristic associated withthe biological sample to stored reference data, and to cause at leastone of an emission of an energy stimulus from one or more of the energyemitters 220 to a biological sample received within at least one of theone or more fluid-flow passageways 110, and a delivery of an activeagent from at least one disinfecting agent reservoir to an interior ofat least one of the one or more fluid-flow passageways 110.

In an embodiment, the computing device 230 is configured to perform acomparison of a real-time measurand associated with a region proximatethe catheter device 102 to infection marker information configured as aphysical data structure 260 and to generate a response based at least inpart on the comparison. In an embodiment, one or more computing devices230 are operably coupled to at least one of the plurality of selectivelyactuatable energy waveguides 202 a, and configured to actuate at leastone of the plurality of selectively actuatable energy waveguides 202 ain response to detected information from the one or more sensors 504.

In an embodiment, the system 100 includes, among other things, means fordetecting at least one characteristic associated with a biologicalsubject including at least one sensor component 502 having one or moresensors 504 and at least one computing device 230 operably coupled tothe at least one sensor component 502. In an embodiment, the system 100includes, among other things, means for detecting at least one of anemitted energy or a remitted energy including an interrogation energyemitter and one or more sensor components 502 having one or more sensors504. In an embodiment, the means for detecting at least one of anemitted energy or a remitted energy includes at least one of atime-integrating optical component 506, a linear time-integratingcomponent 508, a nonlinear optical component 510, or a temporalautocorrelating component 512. In an embodiment, means for detecting atleast one of an emitted energy or a remitted energy includes one or moreone-, two-, or three-dimensional photodiode arrays.

In an embodiment, the system 100 includes, among other things, circuitry550 configured to determine a microorganism colonization event in one ormore regions in the vicinity of the catheter device 102, for example,proximate at least one of the outer surface or the inner surface of thebody structure 104. In an embodiment, circuitry includes one or morecomponents operably coupled (e.g., communicatively coupled,electromagnetically, magnetically, acoustically, optically, inductively,electrically, capacitively coupleable, or the like) to each other. In anembodiment, circuitry includes one or more remotely located components.In an embodiment, remotely located components are operably coupled viawireless communication. In an embodiment, remotely located componentsare operably coupled via one or more receivers, transmitters,transceivers, or the like.

In an embodiment, the circuitry 550 configured to determine themicroorganism colonization event includes at least one sensor component502 having one or more sensors 504. In an embodiment, the circuitry 550configured to determine the microorganism colonization event includes atleast one sensor component 502 having a component identification codeand configured to implement instructions addressed to the sensorcomponent 502 according to the component identification code. In anembodiment, the circuitry 550 configured to determine the microorganismcolonization event includes at least one sensor component 502 operablycoupled to a microorganism colonization biomarker array.

In an embodiment, the circuitry 550 configured to determine themicroorganism colonization event includes a computing device 230operably coupled to one or more sensors 304, and configured to processsensor measurand information, and configured to cause the storing of themeasurand information in a data storage medium. In an embodiment, thecircuitry 550 configured to determine the microorganism colonizationevent includes at least one surface plasmon resonance microarray sensor.In an embodiment, the at least one surface plasmon resonance microarraysensor includes an array of micro-regions configured to capture targetmolecules.

In an embodiment, the circuitry 550 configured to determine themicroorganism colonization event includes at least one of acharge-coupled device, a complementary metal-oxide-semiconductor device,a photodiode image sensor device, a Whispering Gallery Mode (WGM) microcavity device, or a scintillation detector device. In an embodiment, thecircuitry 550 configured to determine the microorganism colonizationevent includes at least one photoelectric device. In an embodiment, thecircuitry 550 configured to determine the microorganism colonizationevent includes an imaging spectrometer. In an embodiment, the circuitry550 configured to determine the microorganism colonization eventincludes at least one of a photo-acoustic imaging spectrometer, athermo-acoustic imaging spectrometer, or aphoto-acoustic/thermo-acoustic tomographic imaging spectrometer.

In an embodiment, the circuitry 550 configured to determine themicroorganism colonization event includes a wavelength-tunable surfaceplasmon resonance sensor. In an embodiment, the circuitry 550 configuredto determine the microorganism colonization event includes a surfaceplasmon resonance microarray sensor having a wavelength-tunablemetal-coated grating. In an embodiment, the circuitry 550 configured todetermine the microorganism colonization event includes one or moreacoustic transducers, electrochemical transducers, optical transducers,piezoelectric transducers, or thermal transducers. In an embodiment, thecircuitry 550 configured to determine the microorganism colonizationevent includes one or more thermal detectors, photovoltaic detectors, orphotomultiplier detectors. In an embodiment, the circuitry 550configured to determine the microorganism colonization event includesone or more charge-coupled devices, complementarymetal-oxide-semiconductor devices, photodiode image sensor devices,whispering gallery mode micro cavity devices, or scintillation detectordevices. In an embodiment, the circuitry 550 configured to determine themicroorganism colonization event includes one or more acoustictransducers. In an embodiment, the circuitry 550 configured to determinethe microorganism colonization event includes one or more densitysensors. In an embodiment, the circuitry 550 configured to determine themicroorganism colonization event includes one or more optical densitysensors. In an embodiment, the circuitry 550 configured to determine themicroorganism colonization event includes one or more photoacousticspectrometers.

In an embodiment, the circuitry 550 configured to determine themicroorganism colonization event includes one or more refractive indexsensors. In an embodiment, the circuitry 550 configured to determine themicroorganism colonization event includes one or more fiber opticrefractive index sensors. In an embodiment, the circuitry 550 configuredto determine the microorganism colonization event includes one or moresurface plasmon resonance sensors. In an embodiment, the circuitry 550configured to determine the microorganism colonization event includesone or more localized surface plasmon resonance sensors.

In an embodiment, the circuitry 550 configured to determine themicroorganism colonization event includes a light transmissive supportand a reflective metal layer. In an embodiment, the circuitry 550configured to determine the microorganism colonization event includesone or more acoustic biosensors, amperometric biosensors, calorimetricbiosensors, optical biosensors, or potentiometric biosensors. In anembodiment, the circuitry 550 configured to determine the microorganismcolonization event includes one or more fluid flow sensors. In anembodiment, the circuitry 550 configured to determine the microorganismcolonization event includes one or more differential electrodes.

In an embodiment, the circuitry 550 configured to determine themicroorganism colonization event includes one or more biomass sensors.In an embodiment, the circuitry 550 configured to determine themicroorganism colonization event includes one or more immunosensors. Inan embodiment, the circuitry 550 configured to determine themicroorganism colonization event includes one or more functionalizedcantilevers. In an embodiment, the circuitry 550 configured to determinethe microorganism colonization event includes a biological moleculecapture layer. In an embodiment, the biological molecule capture layerincludes an array of different binding molecules that specifically bindone or more target molecules.

In an embodiment, the circuitry 550 configured to determine themicroorganism colonization event includes biofilm marker informationconfigured as a physical data structure. In an embodiment, the physicaldata structure includes a characteristic information section havingcharacteristic microbial colonization spectral informationrepresentative of the presence of a microbial colonization proximate thecatheter device 102.

In an embodiment, the system 100 includes, among other things, circuitry560 configured to obtain information. In an embodiment, the circuitry560 configured to obtain information includes circuitry 560 configuredto obtain information associated with a delivery of the optical energy.In an embodiment, the circuitry 560 configured to obtain informationincludes circuitry configured to obtain at least one of a commandstream, a software stream, or a data stream.

In an embodiment, the system 100 includes, among other things, circuitry570 configured to store information. In an embodiment, the circuitry 570configured to store information includes one or more data structures.

In an embodiment, the system 100 includes, among other things, circuitry580 configured to provide information. In an embodiment, the circuitry580 configured to provide information includes circuitry 580 configuredto provide having infection marker information. In an embodiment, thecircuitry 580 configured to provide information includes circuitry 580configured to provide status information. In an embodiment, thecircuitry 580 configured to provide information includes circuitry 580configured to provide information regarding the detection at least oneof the emitted optical energy or the remitted optical energy.

In an embodiment, the system 100 includes, among other things, circuitry590 configured to perform a comparison of the determined at least onecharacteristic associated with the tissue or a biological fluidproximate the catheter device 102 to stored reference data following thedelivery of the energy stimulus. In an embodiment, the catheter device102 includes, among other things, circuitry configured to generate aresponse based at least in part on the comparison. In an embodiment, thecircuitry 590 configured to perform a comparison includes, among otherthings, one or computing devices 230 configured to perform a comparisonof the at least one characteristic associated with the tissue or abiological fluid proximate the catheter device 102 stored reference datafollowing delivery of the sterilizing stimulus, and to generate aresponse based at least in part on the comparison.

In an embodiment, the system 100 is configured to initiate one or moretreatment protocols. In an embodiment, the system 100 is configured toinitiate at least one treatment regimen based on a detected spectralevent. In an embodiment, the system 100 is configured to initiate atleast one treatment regimen based on a detected biomarker event. In anembodiment, the system 100 is configured to initiate at least onetreatment regimen based on a detected infection. In an embodiment, thesystem 100 is configured to initiate at least one treatment regimenbased on a detected fluid vessel abnormality (e.g., an obstruction), adetected biological fluid abnormality (e.g., cerebrospinal fluidabnormalities, hematological abnormalities, components concentration orlevel abnormalities, flow abnormalities, or the like), a detectedbiological parameter, or the like.

Many of the disclosed embodiments can be electrical, electromechanical,software-implemented, firmware-implemented, or other otherwiseimplemented, or combinations thereof. Many of the disclosed embodimentscan be software or otherwise in memory, such as one or more executableinstruction sequences or supplemental information as described herein.For example, in an embodiment, in an embodiment, the catheter device 102includes, among other things, one or more computing devices 230configured to perform a comparison of the at least one characteristicassociated with the biological subject to stored reference data, and togenerate a response based at least in part on the comparison. In anembodiment, one or more computing devices 230 are configured toautomatically control one or more of a frequency, a duration, a pulserate, a duty cycle, or the like associated with an acoustic energygenerated by the one or more transducers 223 a based on a sensedparameter. In an embodiment, one or more computing devices 230 areconfigured to automatically control one or more of a frequency, aduration, a pulse rate, a duty cycle, or the like associated with theacoustic energy generated by the one or more transducers 223 a based ona sensed parameter associated with a region within the biologicalsubject.

Referring to FIG. 5, in an embodiment, the system 100 includes, amongother things, a plurality of actuatable regions 592 that areindependently actuatable between at least a first transmissive state anda second transmissive state. For example, in an embodiment, a catheterdevice 102 includes a plurality of actuatable regions 592 that areindependently actuatable between at least a first transmissive state anda second transmissive state. In an embodiment, the plurality ofactuatable regions 592 are configured to actuate between the at leastfirst transmissive state and the second transmissive state in responseto an applied voltage, electric current, electric potential,electromagnetic field, or the like. For example, in an embodiment, oneor more of the plurality of actuatable regions 592 include a regioncomprising a ferromagnetic fluid whose transmittance changes as therheology of the ferromagnetic fluid changes in response to an appliedpotential. In an embodiment, one or more of the plurality of actuatableregions 592 include a region comprising one or more light valves (e.g.,suspended particle devices, or the like) including a film or a liquidsuspension of conductive material and one or more conductive coatingsthat permit the passage of light in the presence of an applied voltage,and blocks the passage of light in the absences of an applied voltage.

In an embodiment, the plurality of actuatable regions 592 are configuredto actuate electrochemically between the at least first transmissivestate and the second transmissive state. For example, in an embodiment,the plurality of actuatable regions 592 includes one or more of tungstenoxide laminates having optical properties that are electrochemicallycontrollable. In an embodiment, the plurality of actuatable regions 592includes one or more of materials that change color in response to anapplied voltage change.

In an embodiment, the plurality of actuatable regions 592 isenergetically actuatable between the at least first transmissive stateand the second transmissive state. In an embodiment, the plurality ofactuatable regions 592 is UV-actuatable between the at least firsttransmissive state and the second transmissive state. In an embodiment,the plurality of actuatable regions 592 is photochemically actuatablebetween the at least first transmissive state and the secondtransmissive state. In an embodiment, the plurality of actuatableregions 592 is electrically actuatable between the at least firsttransmissive state and the second transmissive state. In an embodiment,the plurality of actuatable regions 592 is acoustically actuatablebetween the at least first transmissive state and the secondtransmissive state.

In an embodiment, the plurality of actuatable regions 592 is configuredto actuate electro-optically between the at least first transmissivestate and the second transmissive state.

In an embodiment, the plurality of actuatable regions 592 is activelycontrollable, via one or more computing device 230, between the at leastfirst transmissive state and the second transmissive state. For example,in an embodiment, one or more computing devices 230 are used to actuatethe plurality of actuatable regions 592 between an optically transparentstate and an optically reflective state. In an embodiment, the pluralityof actuatable regions 592 is controllably actuatable between atransmissive state and a reflective state.

The system 100 can include, among other things, one or more activelycontrollable reflective or transmissive components configured tooutwardly transmit or internally reflect an energy stimulus propagatedtherethrough. In an embodiment, a catheter device 102 includes one ormore actively controllable reflective or transmissive componentsconfigured to outwardly transmit or internally reflect an energystimulus propagated therethrough.

In an embodiment, one or more of plurality of actuatable regions 592 areindependently actuatable between at least a first transmissive state anda second transmissive state via at least one acoustically activematerial. In an embodiment, one or more of plurality of actuatableregions 592 are independently actuatable between at least a firsttransmissive state and a second transmissive state via at least oneelectro-mechanical switch. In an embodiment, one or more of plurality ofactuatable regions 592 are independently actuatable between at least afirst transmissive state and a second transmissive state via at leastone electro-optic switch. In an embodiment, one or more of plurality ofactuatable regions 592 are independently actuatable between at least afirst transmissive state and a second transmissive state via at leastone acousto-optic switch. In an embodiment, one or more of plurality ofactuatable regions 592 are independently actuatable between at least afirst transmissive state and a second transmissive state via at leastone optical switch.

In an embodiment, the system 100 includes, among other things, acomputing device 230 operably coupled to one or more of the plurality ofactuatable regions 592. In an embodiment, the controller is configuredto cause a change between transmissive states based on detectedinformation from the one or more sensors 504.

In an embodiment, the catheter device 102 includes one or more computingdevices 230 operably coupled to one or more of the plurality ofactuatable regions 592. In an embodiment, at least one of the one ormore computing devices 230 is configured to cause a change between theat least first transmissive state and the second transmissive statebased on detected information from the one or more sensors 504. In anembodiment, at least one of the one or more computing devices 230 isconfigured to actuate one or more of the plurality of actuatable regions592 between the at least first transmissive state and the secondtransmissive state based on a comparison of a detected characteristicassociated with the biological sample proximate at least one of theouter surface or the inner surface of the body structure 104.

Referring to FIG. 6, in an embodiment, the system 100 includes, amongother things, one or more surface regions 602 that can be actuated(e.g., controllably actuated, energetically actuated, selectivelyactuated, or the like) between wettability states (e.g., between atleast a first wettability state and a second wettability state). In anembodiment, a catheter device 102 includes one or more surface regions602 that are can be actuated between at least a first wettability stateand a second wettability state. For example, in an embodiment, thecatheter device 102 includes, among other things, one or morecontrollable-wettability-components 604 that are energeticallyactuatable among a plurality of wettability states.

It may be possible to affect adhesion of, for example, bacteria andbiofilm formation by changing at least one of a functional, structural,or chemical character of a surface on a catheter device 102. Forexample, it may be possible to affect adhesion of, for example, bacteriaand biofilm formation by changing surface morphology. It may also bepossible to modulate the adhesion and biofilm formation by modulating atleast one of the functional, structural, or chemical characters of asurface on a catheter device 102. By modulating at least one of afunctional, structural, or chemical character of a surface on a catheterdevice 102, it may also be possible to affect the transport propertiesof a fluid exposed to the surface on a catheter device 102.

In an embodiment, at least one of the one or more fluid-flow passageways110 includes one or more surface regions 602 that are energeticallyactuatable between a substantially hydrophobic state and a substantiallyhydrophilic state. In an embodiment, at least one of the one or morefluid-flow passageways 110 includes a surface region 602 that isenergetically actuatable between at least a first hydrophilic state anda second hydrophilic state. In an embodiment, at least one of the one ormore fluid-flow passageways 110 includes a surface region 602 that isenergetically actuatable between a hydrophobic state and a hydrophilicstate. In an embodiment, at least one of the one or more fluid-flowpassageways 110 includes a surface region 602 having a material that isswitchable between a zwitterionic state and a non-zwitterionic state.

In an embodiment, at least one of the one or more fluid-flow passageways110 includes at least one of an antimicrobial coating and a non-foulingcoating. In an embodiment, at least one of the one or more fluid-flowpassageways 110 includes an antimicrobial and a non-fouling coating. Inan embodiment, at least one of the one or more fluid-flow passageways110 includes a surface region 602 that is energetically actuatablebetween an antimicrobial state and a non-fouling state.

In an embodiment, the body structure 104 includes one or more protrudingelements (e.g., nanostructures, microstructures, pillars, ridges, or thelike) on its surface that recede in the presence of an applied current.The wettability of the surface can be controlled by altering the densityof the protruding elements. See e.g., Spori et al., Cassie-State WettingInvestigated by Means of a Hole-to-Pillar Density Gradient, Langmuir,2010, 26 (12), pp 9465-9473; which is incorporated herein by reference.

In an embodiment, the one or more surface regions are configured tophotochemically actuate between the first wettability state and thesecond wettability state in the presence of an ultraviolet energy. In anembodiment, the one or more surface regions 602 are configured toactuate between the first wettability state and the second wettabilitystate in the presence of an applied potential. In an embodiment, the oneor more surface regions 602 are UV-manipulatable between the firstwettability and the second wettability.

In an embodiment, the one or more surface regions 602 are configured tophotochemically actuate between a substantially hydrophobic state and asubstantially hydrophilic state. In an embodiment, the one or moresurface regions 602 are configured to electrically actuate between asubstantially hydrophobic state and a substantially hydrophilic state.In an embodiment, the one or more surface regions 602 include at leastone ZnO nano-rod film, coating, or material that is UV-manipulatablebetween a superhydrophobic state and superhydrophilic state.

In an embodiment, the one or more surface regions 602 are energeticallycontrollably actuatable between a substantially hydrophobic state and asubstantially hydrophilic state. In an embodiment, the one or moresurface regions 602 are energetically controllably actuatable between atleast a first hydrophilic state and a second hydrophilic state. In anembodiment, the one or more surface regions 602 are energeticallycontrollably actuatable between a hydrophobic state and a hydrophilicstate. In an embodiment, the one or more surface regions 602 include amaterial that is switchable between a zwitterionic state and anon-zwitterionic state.

Controllable-wettability-components 604 can be made using a variety ofmethodologies and technologies including, for example, spray pyrolysis,electro-deposition, electro-deposition onto laser-drilled polymer molds,laser cutting and electro-polishing, laser micromachining,photolithography, surface micro-machining, soft lithography, x-raylithography, LIGA techniques (e.g., X-ray lithography, electroplating,and molding), conductive paint silk screen techniques, conventionalpatterning techniques, injection molding, conventional silicon-basedfabrication methods (e.g., inductively coupled plasma etching, wetetching, isotropic and anisotropic etching, isotropic silicon etching,anisotropic silicon etching, anisotropic GaAs etching, deep reactive ionetching, silicon isotropic etching, silicon bulk micromachining, or thelike), complementary-symmetry/metal-oxide semiconductor (CMOS)technology, deep x-ray exposure techniques, or the like.

Further examples of methodologies and technologies for makingcontrollable wettability components can be found, for example, in thefollowing documents: Feng et al., Reversible Super-hydrophobicity toSuper-hydrophilicity Transition of Aligned ZnO Nanorod Films, J. Am.Chem. Soc., 126, 62-63 (2004), Lin et al., Electrically TunableWettability of Liquid Crystal/Polymer Composite Films, Optics Express 16(22): 17591-598 (2008), Spori et al., Cassie-State Wetting Investigatedby Means of a Hole-to-Pillar Density Gradient, Langmuir, 2010, 26 (12),pp 9465-9473; Wang et al., Photoresponsive Surfaces with ControllableWettability, Journal of Photochemistry and Photobiology C:Photochemistry Reviews, 8 (1): 18-29 (2007), U.S. Pat. No. 6,914,279(issued Jul. 5, 2005), and U.S. Patent Publication No. 2008/0223717(published Sep. 18, 2008); each of which is incorporated herein byreference.

The wettability of a substrate can be determined using varioustechnologies and methodologies including contact angle methods, theGoniometer method, the Whilemy method, the Sessile drop technique, orthe like. Wetting is a process by which a liquid interacts with a solid.Wettability (the degree of wetting) is determined by a force balancebetween adhesive and cohesive force and is often characterized by acontact angle. The contact angle is the angle made by the intersectionof the liquid/solid interface and the liquid/air interface.Alternatively, it is the angle between a solid sample's surface and thetangent of a droplet's ovate shape at the edge of the droplet. Contactangle measurements provide a measure of interfacial energies and conveydirect information regarding the degree of hydrophilicity orhydrophobicity of a surface. For example, superhydrophilic surfaces havecontact angles less than about 5°, hydrophilic surfaces have contactangles less than about 90°, hydrophobic surfaces have contact anglesgreater than about 90°, and superhydrophobic surfaces have contactangles greater than about 150°.

In an embodiment, the catheter device 102 includes a body structure 104including one or more controllable-wettability-components 604 havingswitchable wetting properties. In an embodiment, the catheter device 102includes a body structure 104 including one or morecontrollable-wettability-components 604 that are energeticallyactuatable between at least a first wettability and a secondwettability. In an embodiment, the one or morecontrollable-wettability-components 604 are acoustically, chemically,electro-chemically, electrically, optically, thermally, orphoto-chemically actuatable between at least a first wettability and asecond wettability.

In an embodiment, the one or more controllable-wettability-components604 include at least one acousto-responsive material.

In an embodiment, the one or more controllable-wettability-components604 include at least one photo-responsive material. Non-limitingexamples of photo-responsive materials include SnO, SnO₂, TiO₂, W₂O₃,ZnO, or the like. In an embodiment, the one or morecontrollable-wettability-components 604 include at least one film,coating, or material including SnO, SnO₂, TiO₂, W₂O₃, ZnO, or the like.In an embodiment, the one or more controllable-wettability-components604 are UV-manipulatable between at least a first wettability and asecond wettability. In an embodiment, the one or morecontrollable-wettability-components 604 include one or more ZnO nano-rodfilms, coatings, or materials that are UV-manipulatable between asuperhydrophobic state and superhydrophilic state. In an embodiment, theone or more controllable-wettability-components 604 include at least oneelectrochemically active material. Non-limiting examples ofelectrochemically active materials include electrochemically activepolymers (e.g., polyaniline, polyethylenethioxythiophene, conjugatedpolymer poly(3-hexylthiophene), or the like), or the like.

In an embodiment, the one or more controllable-wettability-components604 include one or more superhydrophobic conducting polypyrrole films,coatings, or components that are electrically switchable between anoxidized state and a neutral state, resulting in reversibly switchablesuperhydrophobic and superhydrophilic properties. (See, e.g., Lahann etal., A Reversibly Switching Surface, 299 (5605): 371-374 (2003) 21:47-51(2003), which is incorporated herein by reference). In an embodiment,the one or more controllable-wettability-components 604 include one ormore electrically isolatable fluid-support structures. See, e.g., U.S.Pat. No. 7,535,692 (issued May 19, 2009), which is incorporated hereinby reference).

In an embodiment, the one or more controllable-wettability-components604 include a plurality of volume-tunable nanostructures. See, e.g.,U.S. Patent Publication No. 2008/0095977 (published Apr. 24, 2008),which is incorporated herein by reference). In an embodiment, the one ormore controllable-wettability-components 604 include one or more tunable(electrically tunable) superhydrophobic conducting polypyrrole films,coatings, or components. See, e.g., Krupenki et al, Electrically TunableSuperhydrophobic Nanostructured Surfaces, Bell Labs Technical Journal 10(3): 161-170 (2009), which is incorporated herein by reference). In anembodiment, the one or more controllable-wettability-components 604include one or more electrically tunable crystal/polymer composites. Inan embodiment, the one or more controllable-wettability-components 604include a switchable surface. See e.g., Gras et al., Intelligent Controlof Surface Hydrophobicity, ChemPhysChem 8 (14): 2036-2050 (2007); eachof which is incorporated herein by reference.

Referring to FIG. 7, in an embodiment the system 100 includes, amongother things, one or more power sources 700. In an embodiment, thecatheter device 102 includes one or more power sources 700. In anembodiment, the power source 700 is electromagnetically, magnetically,acoustically, optically, inductively, electrically, or capacitivelycoupled to at least one of the energy waveguides 202 (e.g., selectivelyactuatable energy waveguides 202 a), the energy emitters 220, thecomputing device 230, and the sensor component 502. Non-limitingexamples of power sources 700 examples include one or more button cells,chemical battery cells, a fuel cell, secondary cells, lithium ion cells,micro-electric patches, nickel metal hydride cells, silver-zinc cells,capacitors, super-capacitors, thin film secondary cells,ultra-capacitors, zinc-air cells, or the like. Further non-limitingexamples of power sources 700 include one or more generators (e.g.,electrical generators, thermo energy-to-electrical energy generators,mechanical-energy-to-electrical energy generators, micro-generators,nano-generators, or the like) such as, for example, thermoelectricgenerators, piezoelectric generators, electromechanical generators,biomechanical-energy harvesting generators, or the like. In anembodiment, the power source 700 includes at least one rechargeablepower source. In an embodiment, the power source 700 is carried by thecatheter device 102. In an embodiment, the catheter device 102 caninclude, among other things, at least one of a battery, a capacitor, ora mechanical energy store (e.g., a spring, a flywheel, or the like).

In an embodiment, the power source 700 is configured to manage a dutycycle associated with emitting an effective dose of the energy stimulusfrom to at least one of the energy waveguides 202 (e.g., selectivelyactuatable energy waveguides 202 a), or the energy emitters 220. In anembodiment, the catheter device 102 is configured to provide a voltage,via a power source 700 operably coupled to at least one of the energywaveguides 202 or the energy emitters 220, across at least a portion ofthe tissue proximate the catheter device 102.

In an embodiment, the power source 700 is configured to wirelesslyreceive power from a remote power supply 730. In an embodiment, thecatheter device 102 includes one or more power receivers 732 configuredto receive power from an in vivo or ex vivo power source. In anembodiment, the power source 700 is configured to wirelessly receivepower via at least one of an electrical conductor or an electromagneticwaveguide. In an embodiment, the power source 700 includes one or morepower receivers 732 configured to receive power from an in vivo or exvivo power source. In an embodiment, the in vivo power source includesat least one of a thermoelectric generator, a piezoelectric generator, amicroelectromechanical systems generator, or a biomechanical-energyharvesting generator.

In an embodiment, the catheter device 102 includes one or moregenerators configured to harvest mechanical energy from for example,acoustic waves, mechanical vibration, blood flow, or the like. Forexample, in an embodiment, the power source 700 includes at least one ofa biological-subject (e.g., human)-powered generator 704, athermoelectric generator 706, piezoelectric generator 708,electromechanical generator 710 (e.g., a microelectromechanical systems(MEMS) generator, or the like), biomechanical-energy harvestinggenerator 712, or the like.

In an embodiment, the biological-subject-powered generator 704 isconfigured to harvest thermal energy generated by the biologicalsubject. In an embodiment, the biological-subject-powered generator 704is configured to harvest energy generated by the biological subjectusing at least one of a thermoelectric generator 706, piezoelectricgenerator 708, electromechanical generator 710 (e.g., amicroelectromechanical systems (MEMS) generator, or the like),biomechanical-energy harvesting generator 712, or the like. For example,in an embodiment, the biological-subject-powered generator 704 includesone or more thermoelectric generators 706 configured to convert heatdissipated by the biological subject into electricity. In an embodiment,the biological-subject-powered generator 704 is configured to harvestenergy generated by any physical motion or movement (e.g., walking,) bybiological subject. For example, in an embodiment, thebiological-subject-powered generator 704 is configured to harvest energygenerated by the movement of a joint within the biological subject. Inan embodiment, the biological-subject-powered generator 704 isconfigured to harvest energy generated by the movement of a fluid (e.g.,biological fluid) within the biological subject.

In an embodiment, the system 100, includes, among other things, atranscutaneous energy transfer system 714. In an embodiment, thecatheter device 102 includes a transcutaneous energy transfer system714. For example, in an embodiment, the catheter device 102 includes oneor more power receivers 732 configured to receive power from at leastone of an in vivo or an ex vivo power source. In an embodiment, thetranscutaneous energy transfer system 714 is electromagnetically,magnetically, acoustically, optically, inductively, electrically, orcapacitively coupled to at least one of the energy waveguides 202 (e.g.,selectively actuatable energy waveguides 202 a), the energy emitters220, the computing device 230, or the sensor component 502.

In an embodiment, the transcutaneous energy transfer system 714 isconfigured to transfer power from at least one of an in vivo or an exvivo power source to the catheter device 102. In an embodiment, thetranscutaneous energy transfer system 714 is configured to transferpower to the catheter device 102 and to recharge a power source 700within the catheter device 102.

In an embodiment, the transcutaneous energy transfer system 714 iselectromagnetically, magnetically, acoustically, optically, inductively,electrically, or capacitively coupleable to an in vivo power supply. Inan embodiment, the transcutaneous energy transfer system 714 includes atleast one electromagnetically coupleable power supply 716, magneticallycoupleable power supply 718, acoustically coupleable power supply 720,optically coupleable power supply 722, inductively coupleable powersupply 724, electrically coupleable power supply 726, or capacitivelycoupleable power supply 728. In an embodiment, the energy transcutaneoustransfer system 714 is configured to wirelessly receive power from aremote power supply 730.

The transcutaneous energy transfer system 714 can include, among otherthings, an inductive power supply. In an embodiment, the inductive powersupply includes a primary winding operable to produce a varying magneticfield. The catheter device 102 can include, among other things, asecondary winding electrically coupled to one or more energy emitters220 for providing a voltage to tissue proximate the catheter device 102in response to the varying magnetic field of the inductive power supply.In an embodiment, the transcutaneous energy transfer system 714 includesa secondary coil configured to provide an output voltage ranging fromabout 10 volts to about 25 volts. In an embodiment, the transcutaneousenergy transfer system 714 is configured to manage a duty cycleassociated with emitting an effective amount of the sterilizing energystimulus from one or more energy emitters 220. In an embodiment, thetranscutaneous energy transfer system 714 is configured to transferpower to the catheter device 102 and to recharge a power source 700within the catheter device 102.

In an embodiment, the catheter device 102 includes one or more coatings(e.g., optically active coatings, reflective coating, opaque coatings,transmissive coatings, etc.). In an embodiment, at least a portion ofthe body structure 104 includes a surface having a coating, coatingsconfigured to treat or reduce the concentration of an infectious agentin the immediate vicinity of the implantable device 102

Non-limiting examples of coatings include anti-biofilm activitycoatings, coatings having self-cleaning properties, coatings havingself-cleaning, and antibacterial activity, or the like.

Further non-limiting examples of coatings include polymeric compositionsthat resist bacterial adhesion, antimicrobial coating, coatings thatcontrollably release antimicrobial agents, quaternary ammonium silanecoatings, chitosan coatings, or the like. Further non-limiting examplesof coatings may be found in, for example, the following documents: U.S.Pat. No. 7,348,021 (issued Mar. 25, 2008), U.S. Pat. No. 7,217,425(issued May 15, 2007), U.S. Pat. No. 7,151,139 (issued Dec. 19, 2006),and U.S. Pat. No. 7,143,709 (issued Dec. 5, 2006); each of which isincorporated herein by reference. In an embodiment, at least a portionof an inner or an outer surface of the implantable device 102 includesone or more self-cleaning coating materials. Non limiting examples ofself-cleaning coating (e.g., Lotus Effect) materials includesuperhydrophobic materials, carbon nanotubes with nanoscopic paraffincoating, or the like. Further non-limiting examples of self-cleaning(e.g., non fouling) coating materials include antimicrobial, andnonfouling zwitterionic polymers, zwitterionic surface formingmaterials, zwitterionic polymers, poly(carboxybetaine methacrylate)(pCBMA), poly(carboxybetaine acrylic amide) (pCBAA), poly(oligo(ethyleneglycol) methyl ether methacrylate) (pOEGMA),poly(N,N-dimethyl-N-(ethoxycarbonylmethyl)-N-[2′-(methacryloyloxy)ethyl]-ammoniumbromide), cationic pC8NMA, switchable pCBMA-1 C2, pCBMA-2, or the like.See, e.g., WO 2008/083390 (published Jul. 10, 2008) (which isincorporated herein by reference).

Further non-limiting examples of coatings include superhydrophobicconducting polypyrrole coatings that are electrically switchable betweenan oxidized state and a neutral state, resulting in reversiblyswitchable superhydrophobic and superhydrophilic properties (see, e.g.,Lahann et al., A Reversibly Switching Surface, 299 (5605): 371-374(2003) 21:47-51 (2003), which is incorporated herein by reference);coatings including electrically isolatable fluid-support structures(see, e.g., U.S. Pat. No. 7,535,692 (issued May 19, 2009), which isincorporated herein by reference); coatings including a plurality ofvolume-tunable nanostructures (see, e.g., U.S. Patent Publication No.2008/0095977 (published Apr. 24, 2008), which is incorporated herein byreference); coatings including re-entrant surface structures (see, e.g.,Tuteja et al., Robust Omniphobic Surfaces, Epub 2008 Nov. 10, 105(47):18200-5 (2008), which is incorporated herein by reference);coatings including superhydrophobic conducting polypyrrole materials,coatings including zwitterionic polymers (see, e.g., Cheng et al., ASwitchable Biocompatible Polymer Surface with Self-Sterilizing andNonfouling Capabilities, Agnew. Chem. Int. Ed. 8831-8834 (2008), whichis incorporated herein by reference); or the like.

Further non-limiting examples of coating include reflective coatings,beam-splitter coatings, broadband multilayer coatings, compositecoatings, dielectric coatings, dielectric reflective coatings (e.g.,dielectric high reflective coatings), grating waveguide coatings (e.g.,high reflectivity grating waveguide coatings), IR reflective coatings,metallic reflective coatings (e.g., metallic high reflective coatings),multilayer coatings, narrow or broad band coatings, optical coatings,partial reflective coatings, polymeric coatings, single layer coatings,UV reflective coatings, UV-IR reflective coatings, or the like, andcombinations thereof. For example, in an embodiment, the catheter device102 includes at least one of an outer internally reflective or an innerinternally reflective coating on the body structure 104. For example, inan embodiment, at least a portion of an inner surface 108 or an outersurface 106 of the catheter device 102 includes a coating configured tointernally reflect at least a portion of an emitted energy stimuluswithin an interior of at least one of the one or more fluid-flowpassageways 110. In an embodiment, at least a portion of the bodystructure 104 includes at least one of an outer internally reflectivecoating or an inner internally reflective coating.

The system 100 can include, among other things, one or more reflectivematerials. In an embodiment, the catheter device 102 includes areflective material. For example, in an embodiment, at least a portionof the body structure 104 includes a reflective material. Non limitingexamples of reflective materials include aluminum, aluminum oxide,barium sulfate, chromium, copper, fluorine, germanium, gold, hafniumdioxide, high refractive index materials, low refractive indexmaterials, magnesium fluoride, nickel, nickel-chromium, platinum,quartz, rhodium, sapphire, silicon dioxide, silver, tantalum pentoxide,thorium fluorides, titanium, titanium dioxide, titanium oxide, tungsten,yttrium oxide, zinc oxide, zinc sulfide, zirconium, zirconium oxide, orthe like, as well as compounds, composites, and mixtures thereof.

For example, in an embodiment, at least a portion of the catheter device102 includes one or more coatings including at least one reflectivematerial. In an embodiment, the reflective material includes at leastone of aluminum, barium sulfate, gold, silver, titanium dioxide, or zincoxide. In an embodiment, the reflective material includes an ultravioletenergy reflective material. In an embodiment, the ultraviolet energyreflective material comprises a metallic film. In an embodiment, theultraviolet energy reflective material comprises enhanced aluminum. Inan embodiment, the ultraviolet energy reflective material comprisesenhanced aluminum overcoated with at least one of magnesium fluoride,silicon dioxide, or silicon monoxide. In an embodiment, the ultravioletenergy reflective material comprises enhanced aluminum overcoated withhigh phosphorous nickel. In an embodiment, the ultraviolet energyreflective material comprises barium sulfate.

In an embodiment, at least a portion of the body structure 104 includesan optical material that permits the transmission of at least a portionof an emitted energy stimulus from an interior of at least one of theone or more fluid-flow passageways 110 to an exterior of at least one ofthe one or more fluid-flow passageways 110. In an embodiment, at least aportion of the body structure 104 includes an optical material thatinternally reflects at least a portion of an emitted energy stimuluspresent within an interior of at least one of the one or more fluid-flowpassageways 110. In an embodiment, at least a portion of the bodystructure 104 includes an optical material that internally reflects atleast a portion of an emitted energy stimulus within an interior of atleast one of the one or more fluid-flow passageways 110, withoutsubstantially permitting the transmission of the emitted energy stimulusthrough an exterior of the body structure 104. In an embodiment, atleast a portion of the body structure 104 includes an optical materialthat internally directs at least a portion of an emitted energy stimulusalong a substantially longitudinal direction of at least one of the oneor more fluid-flow passageways 110. In an embodiment, wherein at least aportion of the body structure 104 includes an optical material thatinternally directs at least a portion of an emitted energy stimulusalong a substantially lateral direction of at least one of the one ormore fluid-flow passageways 110.

In an embodiment, the catheter device 102 includes at least one outerinternally reflective coating on a body structure 104 defining the oneor more fluid-flow passageways 110. In an embodiment, the catheterdevice 102 includes at least one inner internally reflective coating ona body structure 104 defining the one or more fluid-flow passageways110.

The system 100 can include, among other things, one or more reflectivesurfaces (e.g., one or more surfaces reflective to an energy stimulus,etc.). In an embodiment, the catheter device 102 includes one or morereflective surfaces. For example, in an embodiment, at least a portionof the catheter device 102 includes a reflective surface. In anembodiment, the reflective surface forms at least a portion of the bodystructure 104. In an embodiment, at least one of the one or morefluid-flow passageways 110 includes a surface configured to laterallyinternally reflect or longitudinally internally reflect electromagneticradiation transmitted therethrough. For example, in an embodiment, atleast a portion of a body structure defining the one or more fluid-flowpassageways 110 includes a reflective surface capable of reflecting atleast about 50 percent of an energy stimulus emitted by one or more ofthe energy emitters 220 that impinges on the reflective surface. In anembodiment, at least a portion of a body structure defining the one ormore fluid-flow passageways 110 includes a reflective surface that isreflective at a first wavelength and transmissive at a second wavelengthdifferent from the first wavelength. In an embodiment, at least one ofthe one or more fluid-flow passageways 110 includes one or moreinternally reflective components configured to manage a delivery oflight to a biological sample received within the one or more fluid-flowpassageways 110, and to manage a collection of reflected light from thebiological sample.

In an embodiment, the reflective surface is reflective at a firstpolarization and transmissive at a second polarization. In anembodiment, the reflective surface is reflective at a first power leveland transmissive at a second power level. For example, in an embodiment,the reflective surface is opaque at a first power level and transmissiveat a second power level. In an embodiment, the reflective surface isreflective to a first wavelength at a first power level and reflectiveto a second wavelength at a second power level. In an embodiment, atleast a portion of the body structure 104 includes a surface that isreflective to at least one of electromagnetic energy, acoustic energy,or thermal energy.

In an embodiment, at least a portion of the body structure 104 includesan inner surface that is internally reflective to electromagneticradiation. In an embodiment, at least a portion of the body structure104 includes a surface that is internally reflective to ultravioletradiation. In an embodiment, at least a portion of the body structure104 includes a surface that is internally reflective to infraredradiation. In an embodiment, at least a portion of the body structure104 includes a surface configured to laterally internally reflect orlongitudinally internally reflect electromagnetic radiation transmittedwithin the one or more fluid-flow passageways 110. In an embodiment, atleast a portion of the body structure 104 includes a reflective surfacecapable of reflecting at least about 50 percent of an energy stimulusemitted by one or more of the energy emitters 220 that impinges on thereflective surface.

In an embodiment, the system 100 includes, among other things, means forreflecting at least a portion of an emitted energy stimulus within aninterior of at least one of the one or more fluid-flow passageways 110.In an embodiment, the catheter device 102 includes means for reflectingat least a portion of an emitted energy stimulus within an interior ofat least one of the one or more fluid-flow passageways 110. In anembodiment, the means for reflecting at least a portion of an emittedenergy stimulus includes at least one waveguide 202, one or more energyemitters 220, and one or more computing devices 230. In an embodiment,the means for reflecting at least a portion of an emitted energystimulus includes one or more energy emitters 220 and one or morecoatings including optically active materials. In an embodiment, thecatheter device 102 includes means for laterally reflecting orlongitudinally reflecting electromagnetic radiation transmitted withinan interior of at least one of the one or more fluid-flow passageways110. In an embodiment, means for laterally reflecting or longitudinallyreflecting electromagnetic radiation includes at least one waveguide202, one or more energy emitters 220, or one or more computing devices230.

In an embodiment, at least a portion of a body structure 104 includesone or more actively controllable reflective or transmissive componentsconfigured to outwardly transmit or internally reflect an energystimulus propagated through at least one of the one or more fluid-flowpassageways 110. In an embodiment, a computing device 230 is operablycoupled to at least one of the one or more actively controllablereflective and transmissive components. In an embodiment, a computingdevice 230 is configured to cause an outward-transmission orinternal-reflection of an energy stimulus propagated through at leastone of the one or more fluid-flow passageways 110 based on, for example,detected information from a sensor component 502.

In an embodiment, the catheter device 102 includes one or moreinternally reflective components. In an embodiment, the one or moreinternally reflective components form at least a portion of the bodystructure 104. In an embodiment, the one or more internally reflectivecomponents are configured to manage a delivery of interrogation energyto a sample proximate a surface of the catheter device 102, andconfigured to manage a collection of emitted interrogation energy orremitted interrogation energy from the sample. In an embodiment, the oneor more internally reflective components are configured to manage adelivery of interrogation energy to a sample within at least one of theone or more fluid-flow passageways 110, and to manage a collection ofemitted interrogation energy or remitted interrogation energy from thesample. In an embodiment, the at least a portion of the body structure104 includes a reflective surface capable of reflecting at least about50 percent of an energy stimulus that impinges on the reflectivesurface.

In an embodiment, the catheter device 102 includes one or more opticalmaterials forming part of at least a portion of the body structure 104.For example in an embodiment, the catheter device 102 includes one ormore optical materials that are configured to reflect at least a portionof an energy stimulus propagating within the body structure 104. In anembodiment, the one or more optical materials permit the transmission ofat least a portion of an emitted energy stimulus from an interior of atleast one of the one or more fluid-flow passageways 110 to an exteriorof at least one of the one or more fluid-flow passageways 110. In anembodiment, the one or more optical materials are configured tointernally reflect at least a portion of an emitted energy stimuluspresent within an interior of at least one of the one or more fluid-flowpassageways 110.

In an embodiment, at least a portion of a body structure 104 includes anoptical material that internally reflects at least a portion of anemitted energy stimulus within an interior of at least one of the one ormore fluid-flow passageways 110, without substantially permitting thetransmission of the emitted energy stimulus through an exterior of thebody structure. For example, in an embodiment, at least a portion of abody structure 104 includes an optical material that actuates betweenone or more transmissive states and one or more opaque state in thepresences of an applied current or voltage.

In an embodiment, the one or more optical materials are configured tolimit an amount of the energy stimulus that can traverse within the oneor more fluid-flow passageways 110 and through the outer surface 106 ofthe body structure 104. In an embodiment, the one or more opticalmaterials are configured to internally reflect at least a portion of anemitted energy stimulus from one or more of the energy emitters 220 intoan interior of at least one of the one or more fluid-flow passageways110.

In an embodiment, at least a portion of the one or more fluid-flowpassageways 110 includes an optical material that directs at least aportion of an emitted energy stimulus along a substantially longitudinaldirection of at least one of the one or more fluid-flow passageways 110.In an embodiment, at least a portion of the one or more fluid-flowpassageways 110 includes an optical material that directs at least aportion of an emitted energy stimulus along a substantially lateraldirection of at least one of the one or more fluid-flow passageways 110.

Referring to FIG. 8, in an embodiment the system 100 includes, amongother things, a plurality of independently activatable ultravioletenergy delivering substrates 802. In an embodiment, the catheter device102 includes a plurality of independently activatable ultraviolet energydelivering substrates 802 configured to deliver a sterilizing energystimulus to one or more regions proximate the catheter device 102. Forexample, in an embodiment, the plurality of independently activatableultraviolet energy delivering substrates 802 define at least a portionof one or more surfaces of the body structure 104 and configured todeliver a sterilizing energy stimulus to one or more regions proximatethe body structure 104.

In an embodiment, the plurality of independently activatable ultravioletenergy delivering substrates 802 include a radiation emitting coating.In an embodiment, the plurality of independently activatable ultravioletenergy delivering substrates 802 include one or more ultraviolet energynanoparticles. In an embodiment, the plurality of independentlyactivatable ultraviolet energy delivering substrates 802 include alight-emitting material. Non-limiting examples of light-emittingmaterials include electroluminescent materials, UV-electroluminescentmaterials, Near UV-electroluminescent, photoluminescent materials, orthe like. Further non-limiting examples of light-emitting materialsinclude titanium oxide phthalocyanine, p-doped zinc oxide,poly(p-phenylene vinylene)) conjugated polymers, or the like. In anembodiment, the plurality of independently activatable ultravioletenergy delivering substrates 802 include a light-emitting materialconfigured to emit ultraviolet light energy in the presence of an energystimulus.

In an embodiment, the plurality of independently activatable ultravioletenergy delivering substrates 802 include a light-emitting materialconfigured to emit at least one of ultraviolet light B and ultravioletlight C energy in the presence of an energy stimulus. In an embodiment,the plurality of independently activatable ultraviolet energy deliveringsubstrates 802 include a light-emitting material having one or morephoto-absorption bands in the visible region of the electromagneticspectrum. In an embodiment, the plurality of independently activatableultraviolet energy delivering substrates 802 include a light-emittingmaterial configured to emit germicidal light. In an embodiment, theplurality of independently activatable ultraviolet energy deliveringsubstrates 802 include a light-emitting material configured to emitultraviolet light energy in the presence of an electrical potential. Inan embodiment, the plurality of independently activatable ultravioletenergy delivering substrates 802 includes one or more ultraviolet energyemitting phosphors. In an embodiment, the plurality of independentlyactivatable ultraviolet energy delivering substrates 802 includes atrivalent phosphate configured to emit ultraviolet light C energy in thepresence of an energy stimulus.

In an embodiment, the system 100 includes, among other things, acomputing device 230 operably coupled to the plurality of independentlyactivatable ultraviolet energy delivering substrates 802. In anembodiment, the computing device 230 is configured to activate one ormore of the plurality of independently activatable ultraviolet energydelivering substrates 802 in response to detected microbial presenceinformation from the sensor component 502.

In an embodiment, the system 100 includes, among other things, one ormore self-cleaning surface regions 804. In an embodiment, the catheterdevice 102 includes one or more self-cleaning surface regions. Forexample, in an embodiment, the catheter device 102 includes one or moreself-cleaning surface regions 804 including a self-cleaning coatingcomposition.

In an embodiment, the one or more self-cleaning surface regions 804include an energy-activatable self-cleaning material. In an embodiment,the one or more self-cleaning surface regions 804 include a chemicallyactivatable self-cleaning material. In an embodiment, the one or moreself-cleaning surface regions 804 include one or more of titaniumdioxide, superhydrophobic materials, or carbon nanotubes with nanoscopicparaffin coatings. In an embodiment, the one or more self-cleaningsurface regions 804 include one or more antimicrobial agents.

In an embodiment, the one or more self-cleaning surface regions 804include one or more of non-fouling zwitterionic polymers, zwitterionicsurface forming materials, zwitterionic polymers, poly(carboxybetainemethacrylate) (pCBMA), poly(carboxybetaine acrylic amide) (pCBAA),poly(oligo(ethylene glycol) methyl ether methacrylate) (pOEGMA),poly(N,N-dimethyl-N-(ethoxycarbonylmethyl)-N-[2′-(methacryloyloxy)ethyl]-ammoniumbromide), cationic pC8NMA, switchable pCBMA-1 C2, or switchable pCBMA-2.

In an embodiment, the one or more self-cleaning surface regions 804 areconfigured to generate reactive-oxygen-species or areactive-nitrogen-species when exposed to an energy stimulus. In anembodiment, the one or more self-cleaning surface regions 804 areconfigured to generate reactive-oxygen-species or areactive-nitrogen-species in the presence of an applied voltage.

In an embodiment, the one or more self-cleaning surface regions 804include a self-cleaning agent configured to hydrolyze when exposed to anenergy stimulus. In an embodiment, the one or more self-cleaning surfaceregions 804 include a self-cleaning coating configured to degrade whenexposed to an energy stimulus. In an embodiment, the one or moreself-cleaning surface regions 804 include a blood-soluble materialconfigured to degrade when exposed to blood in vivo. In an embodiment,the one or more self-cleaning surface regions 804 include one or morereflective materials or one or more self-cleaning materials. In anembodiment, the one or more self-cleaning surface regions 804 includeone or more reflective coatings or one or more self-cleaning coatings.In an embodiment, the one or more self-cleaning surface regions 804include at least one of an antimicrobial coating or a non-foulingcoating. In an embodiment, the one or more self-cleaning surface regions804 include an antimicrobial or a non-fouling coating. In an embodiment,the one or more self-cleaning surface regions 804 include a surfaceregion that is energetically actuatable between an antimicrobial stateand a non-fouling state.

In an embodiment, the system 100 includes, among other things, one ormore selectively removable protective coatings 806. In an embodiment,the catheter device 102 includes one or more selectively removableprotective coatings 806. For example, in an embodiment, the bodystructure includes a plurality of regions having one or more in vivoselectively removable protective coatings 806 defining at least aportion of one or more surfaces of the body structure 104. In anembodiment, the plurality of regions having the one or more in vivoselectively removable protective coatings 806 define a spaced-apartpattern of at least one repeating region comprising at least a firstselectively removable protective coating material.

In an embodiment, the one or more in vivo selectively removableprotective coatings 806 include a cell-rejecting compound. In anembodiment, the one or more in vivo selectively removable protectivecoatings 806 includes at least one of copper or silver. In anembodiment, the one or more in vivo selectively removable protectivecoatings 806 include a cell-rejecting polymer. In an embodiment, the oneor more in vivo selectively removable protective coatings 806 includesat least one of poly(ethylene oxide), poly(ethylene glycol), orpoly(styrene-isobutylene styrene). In an embodiment, the one or more invivo selectively removable protective coatings 806 includes aphoto-degradable material. In an embodiment, the one or more in vivoselectively removable protective coatings 806 includes a bioerodiblematerial. In an embodiment, the one or more in vivo selectivelyremovable protective coatings 806 includes body fluid soluble material.In an embodiment, the one or more in vivo selectively removableprotective coatings 806 includes blood erodible material.

In an embodiment, the catheter device 102 includes circuitry 550configured to determine the microorganism colonization event in one ormore of the plurality of regions having the one or more in vivoselectively removable protective coatings 806. In an embodiment, thecircuitry 550 configured to determine the microorganism colonizationevent includes biofilm marker information configured as a physical datastructure. In an embodiment, the circuitry 550 configured to determinethe microorganism colonization event includes one or more computingdevices 230 operably coupled to one or more sensors 504 and configuredto cause a removal of at least one of the one or more in vivoselectively removable protective coatings 806 one or more in vivoselectively removable protective coatings 806 based on detectedinformation from the one or more sensors. In an embodiment, the bodystructure 104 is configured to transmit at least a portion of an emittedenergy stimulus propagated within the body structure though one or moreof the plurality of regions having had an in vivo selectively removableprotective coating removed.

Referring to FIG. 9, the system 100 includes, among other things, one ormore active agent assemblies 900. In an embodiment, the catheter device102 includes at least one active agent assembly 900 including one ormore reservoirs 902 (e.g., active agent reservoirs energy, samplereservoirs, biological sample reservoirs, tracer agent reservoirs, orthe like, or combinations thereof).

In an embodiment, the active agent assembly 900 is configured to deliverone or more active agents from the at least one reservoir 902 to one ormore regions proximate the body structure 104. For example, in anembodiment, the catheter device 102 includes one or more active agentassemblies 900 configured to deliver at least one active agent from theat least one reservoir 902 to at least one of a region 906 proximate anouter surface 106 and a region 908 proximate an inner surface 108 of thecatheter device 102.

In an embodiment, the reservoir 902 includes at least one active agentcomposition having one or more active agents. Non-limiting examples ofactive agents include adjuvants, allergens, analgesics, anesthetics,antibacterial agents, antibiotics, antifungals, anti-inflammatory agents(e.g., nonsteroidal anti-inflammatory drugs), antimicrobials,antioxidants, antipyretics, anti-tumor agents, antivirals, bio-controlagents, biologics or bio-therapeutics, chemotherapy agents, disinfectingagents, energy-activatable active agents, immunogens, immunologicaladjuvants, immunological agents, immuno-modulators, immuno-responseagents, immuno-stimulators (e.g., specific immuno-stimulators,non-specific immuno-stimulators, or the like), immuno-suppressants,non-pharmaceuticals (e.g., cosmetic substances, or the like),pharmaceuticals, protease inhibitors or enzyme inhibitors, receptoragonists, receptor antagonists, therapeutic agents, tolerogens,toll-like receptor agonists, toll-like receptor antagonists, vaccines,or combinations thereof.

Further non-limiting examples of active agents include nonsteroidalanti-inflammatory drugs such as acemetacin, aclofenac, aloxiprin,amtolmetin, aproxen, aspirin, azapropazone, benorilate, benoxaprofen,benzydamine hydrochloride, benzydamine hydrochloride, bromfenal,bufexamac, butibufen, carprofen, celecoxib, choline salicylate,clonixin, desoxysulindac, diflunisal, dipyone, droxicam, etodolac,etofenamate, etoricoxib, felbinac, fenbufen, fenoprofen, fentiazac,fepradinol, floctafenine, flufenamic acid, indomethacin, indoprofen,isoxicam, ketoralac, licofelone, lomoxicam, loxoprofen, magnesiumsalicylate, meclofenamic acid, meclofenamic acid, mefenamic acid,meloxicam, morniflumate, niflumic acid, nimesulide, oxaprozen,phenylbutazone, piketoprofen, piroxicam, pirprofen, priazolac,propyphenazone, proquazone, rofecoxib, salalate, salicylamide, salicylicacid, sodium salicylate, sodium thiosalicylate, sulindac, suprofen,tenidap, tenoxicam, tiaprofenic acid, tolmetin, tramadol, trolaminesalicylate, zomepirac, or the like.

Further non-limiting examples of active agents includeenergy-activatable active agents (e.g., chemical energy, electricalresistance, laser energy, terahertz energy, microwave energy, opticalenergy, radio frequency energy, acoustic energy, thermal energy, thermalresistance heating energy, or ultrasonic energy activatable activeagents, or the like) or the like.

In an embodiment, the active agent includes at least one active agentthat selectively targets bacteria. For example, in an embodiment, theactive agent includes at least one bacteriophage that can, for example,selectively target bacteria. Bacteriophages generally comprise an outerprotein hull enclosing genetic material. The genetic material can be,for example, ssRNA, dsRNA, ssDNA, or dsDNA. Bacteriophages are generallysmaller than the bacteria they destroy generally ranging from about 20nm to about 200 nm. Non-limiting examples of bacteriophages include T2,T4, T6, phiX-174, MS2, or the like). In an embodiment, the active agentincludes at least one energy-activatable agent that selectively targetsbacteria. For example, in an embodiment, the active agent includes atleast one triplet excited-state photosensitizer that can, for example,selectively target bacteria.

Further non-limiting examples of active agents include tripletexcited-state photosensitizers, reactive oxygen species, reactivenitrogen species, any other inorganic or organic ion or molecules thatinclude oxygen ions, free radicals, peroxides, or the like. Furthernon-limiting examples of active agents include compounds, molecules, ortreatments that elicit a biological response from any biologicalsubject. Further non-limiting examples of disinfecting agents includetherapeutic agents (e.g., antimicrobial therapeutic agents),pharmaceuticals (e.g., a drug, a therapeutic compound, pharmaceuticalsalts, or the like) non-pharmaceuticals (e.g., a cosmetic substance, orthe like), neutraceuticals, antioxidants, phytochemicals, homeopathicagents, or the like. Further non-limiting examples of disinfectingagents include peroxidases (e.g., haloperoxidases such aschloroperoxidase, or the like), oxidoreductase (e.g., myeloperoxidase,eosinophil peroxidase, lactoperoxidase, or the like) oxidases, or thelike.

Further non-limiting examples of active agents include one or morepore-forming toxins. Non limiting examples of pore-forming toxinsinclude beta-pore-forming toxins, e.g., hemolysin, Panton-Valentineleukocidin S, aerolysin, Clostridial epsilon-toxin; binary toxins, e.g.,anthrax, C. perfringens Iota toxin, C. difficile cytolethal toxins;cholesterol-dependent cytolysins; pneumolysin; small pore-formingtoxins; and gramicidin A.

Further non-limiting examples of active agents include one or morepore-forming antimicrobial peptides. Antimicrobial peptides represent anabundant and diverse group of molecules that are naturally produced bymany tissues and cell types in a variety of invertebrate, plant andanimal species. The amino acid composition, amphipathicity, cationiccharge and size of antimicrobial peptides allow them to attach to andinsert into microbial membrane bilayers to form pores leading tocellular disruption and death. More than 800 different antimicrobialpeptides have been identified or predicted from nucleic acid sequences,a subset of which are available in a public database (see, e.g., Wang &Wang, Nucleic Acids Res. 32:D590-D592, 2004);http://aps.unmc.edu/AP/main.php, which is incorporated herein byreference).

More specific examples of antimicrobial peptides include, among others,anionic peptides, e.g., maximin H5 from amphibians, small anionicpeptides rich in glutamic and aspartic acids from sheep, cattle andhumans, and dermcidin from humans; linear cationic alpha-helicalpeptides, e.g., cecropins (A), andropin, moricin, ceratotoxin, andmelittin from insects, cecropin P1 from Ascaris nematodes, magainin 2,dermaseptin, bombinin, brevinin-1, esculentins and buforin II fromamphibians, pleurocidin from skin mucous secretions of the winterflounder, seminalplasmin, BMAP, SMAP (SMAP29, ovispirin), PMAP fromcattle, sheep and pigs, CAP18 from rabbits and LL37 from humans;cationic peptides enriched for specific amino acids, e.g.,praline-containing peptides including abaecin from honeybees, praline-and arginine-containing peptides including apidaecins from honeybees,drosocin from Drosophila, pyrrhocoricin from European sap-sucking bug,bactenicins from cattle (Bac7), sheep and goats and PR-39 from pigs,praline- and phenylalanine-containing peptides including prophenin frompigs, glycine-containing peptides including hymenoptaecin fromhoneybees, glycine- and praline-containing peptides includingcoleoptericin and holotricin from beetles, tryptophan-containingpeptides including indolicidin from cattle, and small histidine-richsalivary polypeptides, including histatins from humans and higherprimates; anionic and cationic peptides that contain cysteine and fromdisulfide bonds, e.g., peptides with one disulphide bond includingbrevinins, peptides with two disulfide bonds including alpha-defensinsfrom humans (HNP-1, HNP-2, cryptidins), rabbits (NP-1) and rats,beta-defensins from humans (HBD1, DEFB118), cattle, mice, rats, pigs,goats and poultry, and rhesus theta-defensin (RTD-1) from rhesus monkey,insect defensins (defensin A); and anionic and cationic peptidefragments of larger proteins, e.g., lactoferricin from lactoferrin,casocidin 1 from human casein, and antimicrobial domains from bovinealpha-lactalbumin, human hemoglobin, lysozyme, and ovalbumin (see, e.g.,Brogden, Nat. Rev. Microbiol. 3:238-250, 2005, which is incorporatedherein by reference).

Further non-limiting examples of active agents include antibacterialdrugs. Non-limiting examples of antibacterial drugs include beta-lactamcompounds such as penicillin, methicillin, nafcillin, oxacillin,cloxacillin, dicloxacillin, ampicillin, ticarcillin, amoxicillin,carbenicillin, and piperacillin; cephalosporins and cephamycins such ascefadroxil, cefazolin, cephalexin, cephalothin, cephapirin, cephradine,cefaclor, cefamandole, cefonicid, cefuroxime, cefprozil, loracarbef,ceforanide, cefoxitin, cefmetazole, cefotetan, cefoperazone, cefotaxime,ceftazidine, ceftizoxine, ceftriaxone, cefixime, cefpodoxime, proxetil,cefdinir, cefditoren, pivoxil, ceftibuten, moxalactam, and cefepime;other beta-lactam drugs such as aztreonam, clavulanic acid, sulbactam,tazobactam, ertapenem, imipenem, and meropenem; other cell wall membraneactive agents such as vancomycin, teicoplanin, daptomycin, fosfomycin,bacitracin, and cycloserine; tetracyclines such as tetracycline,chlortetracycline, oxytetracycline, demeclocycline, methacycline,doxycycline, minocycline, and tigecycline; macrolides such aserythromycin, clarithromycin, azithromycin, and telithromycin;aminoglycosides such as streptomycin, neomycin, kanamycin, amikacin,gentamicin, tobramycin, sisomicin, and netilmicin; sulfonamides such assulfacytine, sulfisoxazole, silfamethizole, sulfadiazine,sulfamethoxazole, sulfapyridine, and sulfadoxine; fluoroquinolones suchas ciprofloxacin, gatifloxacin, gemifloxacin, levofloxacin,lomefloxacin, moxifloxacin, norfloxacin, and ofloxacin; antimycobacteriadrugs such as isoniazid, rifampin, rifabutin, rifapentine, pyrazinamide,ethambutol, ethionamide, capreomycin, clofazimine, and dapsone; andmiscellaneous antimicrobials such as colistimethate sodium, methenaminehippurate, methenamine mandelate, metronidazole, mupirocin,nitrofurantoin, polymyxin B, clindamycin, choramphenicol,quinupristin-dalfopristin, linezolid, spectrinomycin, trimethoprim,pyrimethamine, and trimethoprim-sulfamethoxazole.

Further non-limiting examples of active agents include antifungalagents. Non-limiting examples of antifungal agents includeanidulafungin, amphotericin B, butaconazole, butenafine, caspofungin,clotrimazole, econazole, fluconazole, flucytosine griseofulvin,itraconazole, ketoconazole, miconazole, micafungin, naftifine,natamycin, nystatin, oxiconazole, sulconazole, terbinafine, terconazole,tioconazole, tolnaftate, and/or voriconazole.

Further non-limiting examples of active agents include anti-parasiteagents. Non-limiting examples of anti-parasite agents includeantimalaria drugs such as chloroquine, amodiaquine, quinine, quinidine,mefloquine, primaquine, sulfadoxine-pyrimethamine, atovaquone-proguanil,chlorproguanil-dapsone, proguanil, doxycycline, halofantrine,lumefantrine, and artemisinins; treatments for amebiasis such asmetronidazole, iodoquinol, paromomycin, diloxanide furoate, pentamidine,sodium stibogluconate, emetine, and dehydroemetine; and otheranti-parasite agents such as pentamidine, nitazoxanide, suramin,melarsoprol, eflornithine, nifurtimox, clindamycin, albendazole, andtinidazole. Further non-limiting examples of active agents include ionicsilver, (SilvaSorb®, Medline Industries, Inc), anti-microbial silvercompositions (Arglaes®, Medline Industries, Inc), or the like. Furthernon-limiting examples of active agents include superoxide-formingcompositions. Further non-limiting examples of active agents includeoxazolidinones, gram-positive antibacterial agents, or the like. See,e.g., U.S. Pat. No. 7,322,965 (issued Jan. 29, 2008), which isincorporated herein by reference.

In an embodiment, the active agent includes one or more antimicrobialagents. In an embodiment, the antimicrobial agent is an antimicrobialpeptide. Amino acid sequence information for a subset of these can befound as part of a public database (see, e.g., Wang & Wang, NucleicAcids Res. 32:D590-D592, 2004); http://aps.unmc.edu/AP/main.php, whichis incorporated herein by reference). Alternatively, a phage library ofrandom peptides can be used to screen for peptides with antimicrobialproperties against live bacteria, fungi and/or parasites. The DNAsequence corresponding to an antimicrobial peptide can be generated exvivo using standard recombinant DNA and protein purification techniques.

In an embodiment, one or more of the active agent include chemicalssuitable to disrupt or destroy cell membranes. For example, someoxidizing chemicals can withdraw electrons from a cell membrane causingit to, for example, become destabilized. Destroying the integrity ofcell membranes of, for example, a pathogen can lead to cell death.

In an embodiment, the catheter device 102 includes one or more activeagent assemblies 900 configured to deliver at least one active agentfrom the at least one reservoir 902 to at least one of a regionproximate an outer and an inner surface of the catheter device 102. Inan embodiment, at least one of the one or more active agent assemblies900 is configured to deliver one or more active agents in a spatiallypatterned distribution. In an embodiment, at least one of the one ormore active agent assemblies 900 is configured to deliver one or moreactive agents in a temporally patterned distribution. In an embodiment,the catheter device 102 includes a plurality ofspaced-apart-release-ports 910 adapted to deliver one or more activeagents in a spatially patterned distribution. In an embodiment, thecatheter device 102 includes a plurality of spaced apartcontrollable-release ports 910 adapted to deliver one or more activeagents in a spatially patterned distribution.

In an embodiment, the catheter device 102 includes at least onecomputing device 230 operably coupled to one or more of the plurality ofspaced-apart-release-ports 910 and configured to actuate one or more ofthe plurality of spaced-apart-release-ports between an active agentdischarge state and an active agent retention state. In an embodiment, acomputing device 230 is operable to actuate one or more of the pluralityof spaced-apart-release-ports 910 between an active agent dischargestate and an active agent retention state based on a comparison of adetected characteristic to stored reference data.

In an embodiment, the computing device 230 is operably coupled to theactive agent assembly and configured to actively control one or more ofthe plurality of spaced-apart-release-ports 910. In an embodiment, atleast one computing device 230 is operably coupled to one or more of thespaced-apart controllable-release ports 910 and configured to control atleast one of a port release rate, a port release amount, and a portrelease pattern associated with a delivery of the one or more activeagents. In an embodiment, at least one processor 232 is operably coupledto the active agent assembly 900 and configured to control at least oneof a port release rate, a port release amount, or a port release patternassociated with the delivery of the one or more active agents from theat least one reservoir 902 to an interior of at least one of the one ormore fluid-flow passageways 110.

In an embodiment, a computing device 230 is operably coupled to theactive agent assembly 900 and configured to control at least one of anactive agent delivery rate, an active agent delivery amount, an activeagent delivery composition, a port release rate, a port release amount,or a port release pattern.

In an embodiment, at least one computing device 230 is operably coupledto one or more of the plurality of spaced-apart-release-ports 910 andconfigured to actuate one or more of the plurality ofspaced-apart-release-ports 910 between an active agent discharge stateand an active agent retention state. In an embodiment, the catheterdevice 102 includes one or more active agent assemblies 900 includingone or more reservoirs 902 configured to deliver at least one activeagent from the at least one reservoir 902 to at least one of a region904 proximate an outer surface 108 or a region 906 proximate an innersurface 110 of the catheter device 102.

In an embodiment, the catheter device 102 includes one or more activeagent assemblies 900 configured to deliver one or more disinfectingagents. In an embodiment, the catheter device 102 includes one or moreactive agent assemblies 900 configured to deliver at least oneenergy-activatable agent from at least one reservoir 902 to, forexample, an interior of one or more fluid-flow passageways 110.Non-limiting examples of energy-activatable active agents includeradiation absorbers, light energy absorbers, X-ray absorbers,photoactive agents, or the like. Non-limiting examples of photoactiveagents include, but are not limited to photoactive antimicrobial agents(e.g., eudistomin, photoactive porphyrins, photoactive TiO₂,antibiotics, silver ions, antibodies, nitric oxide, or the like),photoactive antibacterial agents, photoactive antifungal agents, or thelike. Further non-limiting examples of energy-activatable agent includesenergy-activatable disinfecting agents, photoactive agents, or ametabolic precursor thereof. In an embodiment, the at least oneenergy-activatable agent includes at least one X-ray absorber. In anembodiment, the at least one energy-activatable agent includes at leastone radiation absorber.

In an embodiment, the active agent assembly 900 is configured to deliverat least one energy-activatable disinfecting agent from at least onereservoir 902 to a biological sample proximate the catheter device 102.In an embodiment, the catheter device 102 includes one or more activeagent assemblies 900 configured to deliver at least oneenergy-activatable disinfecting agent from the at least one reservoir902 to tissue proximate at least one surface of the catheter device 102.In an embodiment, at least one of the one or more active agentassemblies 900 is configured to deliver at least one energy-activatabledisinfecting agent in a spatially patterned distribution. In anembodiment, the active agent assembly 900 is configured to deliver atleast one energy-activatable steroid to tissue proximate the at leastone outer surface 108 of the catheter device 102.

In an embodiment, the at least one reservoir 902 includes, among otherthings, an acceptable carrier. In an embodiment, at least one activeagent is carried by, encapsulated in, or forms part of, anenergy-sensitive (e.g., energy-activatable), carrier, vehicle, vesicle,pharmaceutical vehicle, pharmaceutical carrier, pharmaceuticallyacceptable vehicle, pharmaceutically acceptable carrier, or the like.

Non-limiting examples of carriers include any matrix that allows fortransport of, for example, a disinfecting agent across any tissue, cellmembranes, or the like of a biological subject, or that is suitable foruse in contacting a biological subject, or that allows for controlledrelease formulations of the compositions disclosed herein. Furthernon-limiting examples of carriers include at least one of creams,liquids, lotions, emulsions, diluents, fluid ointment bases, gels,organic and inorganic solvents, degradable or non-degradable polymers,pastes, salves, vesicle, or the like. Further non-limiting examples ofcarriers include cyclic oligosaccharides, ethasomes, hydrogels,liposomes, micelle, microspheres, lipospheres, niosomes, non-ionicsurfactant vesicles, organogels, phospholipid surfactant vesicles,transfersomes, and virosomes. Further non-limiting examples ofenergy-sensitive carriers or the like include electricalenergy-sensitive, light sensitive, pH-sensitive, ion-sensitive, acousticenergy sensitive, and ultrasonic energy sensitive carriers. Furthernon-limiting examples of carriers can be found in, for example, Timko etal., Remotely Triggerable Drug Delivery Systems. Advanced Materials,n/a. doi: 10.1002/adma.201002072 (2010); Tsutsui et al., The Use ofMicrobubbles to Target Drug Delivery, Cardiovascular Ultrasound, 2:23doi: 10.1186/1476-7120-2-23 (2004); each of which is incorporated hereinby reference.

In an embodiment, one or more active agents are carried byenergy-sensitive vesicles (e.g., energy-sensitive cyclicoligosaccharides, ethasomes, hydrogels, liposomes, micelles,microspheres, niosomes, lipospheres, non-ionic surfactant vesicles,organogels, phospholipid surfactant vesicles, transfersomes, virosomes,or the like). In an embodiment, at least one of the one or more energyemitters 220 is configured to provide energy of a dose sufficient toliberate at least a portion of an active agent carried by theenergy-sensitive vesicles.

In an embodiment, one or more active agents are conjugated to orencapsulated in one or more remotely triggerable delivery systemsconfigured for release from the catheter device 102. In an embodiment,the triggerable delivery system is designed for single release or forrepeated release of one or more active agents. In an embodiment, thetriggered delivery system releases one or more active agents in responseto temperature, electromagnetic radiation (e.g., UV, visible or nearinfrared radiation, radiofrequency, microwave, or the like), a magneticfield, ultrasound, or the like. For example, in an embodiment,application of electromagnetic radiation, a magnetic field, ultrasound,or the like can induce a thermal change sufficient for release of one ormore active agents from a temperature-sensitive triggerable deliverysystem.

In an embodiment, the triggerable delivery system includes, among otherthings, liposomes, polymer vesicles, polymeric liposomes,polyelectrolyte microcontainers, multilayered capsules, micelles,dendrimers, microbubbles, or the like. In an embodiment, polymers arecross-linked with photolabile groups, allowing active agents to bereleased in response to light. An example of a photocleavable moleculeincludes among other things 2-nitrobenzyl ester. In an embodiment, oneor more active agents are released from the delivery system by thereversible isomerization of molecules upon irradiation with near-UV orvisible light. UV irradiation, for example, can induce phase transitionsof natural and synthetic polymers, accompanied by reversible volumechanges, allowing active agents to be released as the polymers shrink orswell. For example, azobenzenes which contain two phenyl groups andundergo conformational changes in response to UV light can be used aspart of a molecular valve to control release of one or more activeagents through a channel protein incorporated into liposomes.

In an embodiment, polymers are combined with magnetic oxidenanoparticles to form ferrogel materials which deform in response to amagnetic field, allowing for triggerable release of one or more activeagents. In an embodiment, ferrogel materials include, among otherthings, ferrite particles cross-linked to or embedded in poly(vinylalcohol), polyNIPAm, or gelatin. In the case of microbubbles, in anembodiment, ultrasound is used to trigger release of a gas from astabilizing shell of lipid or polymer or, under conditions of lowfrequency, ultrasound can induce cavitation of microbubbles anddisruption of nearby cell membranes sufficient to allow passage into thecells of co-administered active agents.

In an embodiment, the triggerable delivery system includes, among otherthings, metallic nanostructures, and particularly gold nanostructures.In an embodiment, under optical irradiation, electrons associated withmetallic nanostructures oscillate in phase, a phenomenon referred to assurface plasmon resonance. In their excited state, the electronssubsequently decay through either radiative (fluorescence), nonradiative(lattice rearrangement), or photothermal (local heating) pathways. Thespecific decay pathway is dependent on the geometry of the nanoparticlesand the nature of the excitation pulse. In an embodiment, latticerearrangement and local heating induced in this manner can be used totrigger delivery of active agents. As a non-limiting example, goldnanorods can be melted into nanospheres using ultrafast laser pulses,effectively triggering release of surface-bound active agent as the goldlattice atoms rearrange. Heterogeneous mixtures of rods or rodlikestructures with distinct geometries and resonant frequencies enableselective release of multiple ligands. For example, gold nanocapsulesand gold nanorods exhibit SPR longitudinal modes at 800 nm and 1100 nm,respectively. Pulsed laser irradiation centered at either of these tworesonant frequencies yields selective melting of the correspondingnanoparticles and selective release of associated active agents. Weaklybound ligands can also be released by localized heating below thenanoparticle melting threshold. Gold nanoparticles can also beconfigured into nanoshells (i.e., hollow or enclosed solid cores) ornanocages (i.e., hollow interior and porous walls).

In an embodiment, the triggerable delivery system includes a combinationof liposomes or polymers and gold nanoparticles. In an embodiment, goldnanoparticle are combined with temperature-sensitive polymers fortriggered release with near infrared radiation. In an embodiment, one ormore active agents can be incorporated into gold cages covered withmonolayers of heat labile polymer chains, formed by polymerizingpolymers, e.g., n-isopropylacrylamine (NIPAm) and acrylamide (Am)precursors, with a disulfide initiator, the poly(NIPAm-co-Am) chainsattached to the surface of the gold cages by Au—S linkages, forming ahydrophobic layer with lower critical solution temperatures tunablebetween about 32° C. to about 50° C. In another non-limiting example,one or more active agents can be co-encapsulated in liposomes in thepresence of gold nanoparticles, the latter of which, in the presence ofnear infrared radiation, generate heat sufficient to disrupt theliposomes.

In an embodiment, triggerable membranes can be used as walls ofreservoirs, allowing a large quantity of active agent to be containedand repeatedly released over time. For example, nanocomposite membranesconsisting of a thermosensitive material, e.g., polyNIPAm-based nanogelsand magnetic particles embedded in an ethylcellulose matrix, can bedesigned to achieve on-demand drug delivery upon application of an ACmagnetic field. Alternatively, one or more active agents can be releasedfrom magnetically actuated microchips configured with an array of wellsand a biodegradable covering such as, for example, poly-(D,L-lacticacid). In an embodiment, an active agent can be electrodeposited onto athin film in the presence of magnetic oxide, e.g., Fe₃O₄/SiO₂, andreleased in response to a magnetic field. For further examples oftriggerable delivery systems, see e.g., Timko et al., RemotelyTriggerable Drug Delivery Systems. Advanced Materials, n/a. doi:10.1002/adma.201002072 (2010); Tsutsui et al., The Use of Microbubblesto Target Drug Delivery, Cardiovascular Ultrasound,2:23doi:10.1186/1476-7120-2-23 (2004); each of which is incorporatedherein by reference.

In an embodiment, the catheter device 102 includes one or morebiological sample reservoirs. In an embodiment, the catheter device 102includes one or more biological specimen reservoirs. In an embodiment,the catheter device 102 includes one or more biological samplereservoirs. In an embodiment, the catheter device 102 includes one ormore active agent assemblies 900 configured to receive one or morebiological samples. In an embodiment, the biological sample reservoir isplaced under the scalp of a user. In an embodiment, the biologicalsample reservoir is configured to allow for the removal of biologicalsample with a syringe. In an embodiment, the reservoir 902 includes asensor component 502 configured to detect, for example, bacteria, cancercells, blood, or proteins of a fluid sample received within. In anembodiment, the reservoir 902 is configured to allow the injection orintroduction of antibiotics for cerebrospinal fluid infection orchemotherapy medication. In an embodiment, the reservoir 902 includescircuitry configured to detect at least one physical quantity,environmental attribute, or physiologic characteristic associated with,for example, a shunting process.

In an embodiment, the catheter device 102 includes one or more activeagent assemblies 900 configured to deliver at least one tracer agentfrom at least one reservoir 902. In an embodiment, the catheter device102 includes one or more active agent assemblies 900 including one ormore tracer agent reservoirs configured to deliver at least one traceragent. In an embodiment, the one or more active agent assemblies 900 areconfigured to deliver one or more tracer agents. Non-limiting examplesof tracer agents include one or more in vivo clearance agents, magneticresonance imaging agents, contrast agents, dye-peptide compositions,fluorescent dyes, or tissue specific imaging agents. In an embodiment,the one or more tracer agents include at least one fluorescent dye. Inan embodiment, the one or more tracer agents include indocyanine green.

In an embodiment, active agent assembly 900 is further configured toconcurrently or sequentially deliver one or more tracer agents and oneor more energy-activatable disinfecting agents. In an embodiment, theactive agent assembly 900 is further configured to deliver one or moretracer agents for indicating the presence or concentration of one ormore energy-activatable disinfecting agents in at least a regionproximate the catheter device 102. In an embodiment, the active agentassembly 900 is further configured to deliver one or more tracer agentsfor indicating the response of the one or more energy-activatabledisinfecting agents to energy emitted from the one or moreenergy-emitting emitters 220.

In an embodiment, at least one of the one or more fluid-flow passageways110 includes a photoactive agent. In an embodiment, at least one of theone or more fluid-flow passageways 110 includes a photoactive coatingmaterial. In an embodiment, at least one of the one or more fluid-flowpassageways 110 includes a light-emitting material configured to emitultraviolet light energy in the presence of an energy stimulus. In anembodiment, at least one of the one or more fluid-flow passageways 110includes a light-emitting material configured to emit ultraviolet lightenergy in the presence of an electrical potential. In an embodiment, atleast one of the one or more fluid-flow passageways 110 includes aphotoactive agent having one or more photoabsorption bands in thevisible region of the electromagnetic spectrum.

In an embodiment, the catheter device 102 includes one or more activeagent assemblies 900 configured to deliver one or more ultravioletenergy absorbing agents from at least one reservoir 902 to one or moreregions proximate the surface of the catheter device 102. In anembodiment, the catheter device 102 includes one or more energywaveguides 202 configured to guide an emitted ultraviolet energystimulus to one or more regions proximate the surface of the catheterdevice 102.

In an embodiment, the reservoir 902 includes at least one ultravioletenergy absorbing agent having an absorption spectra in a germicidallight range. In an embodiment, the reservoir 902 includes at least oneultraviolet energy absorbing agent having an absorption spectra of about100 nanometers to about 400 nanometers. In an embodiment, the onereservoir 902 includes at least one ultraviolet energy absorbing agenthaving an absorption spectra of about 100 nanometers to about 290nanometers. In an embodiment, the reservoir 902 includes at least oneultraviolet energy absorbing agent having an absorption spectra of about200 nanometers to about 290 nanometers. In an embodiment, the reservoir902 includes at least one ultraviolet energy absorbing agent having anabsorption spectra of about 280 nanometers to about 320 nanometers.

In an embodiment, the reservoir 902 includes at least one ultravioletabsorbing compound. In an embodiment, the reservoir 902 includes atleast one of a nucleotide composition, a nucleoside composition, and apeptide nucleic acid composition. In an embodiment, the reservoir 902includes a synthetic nucleic acid composition. In an embodiment, the onereservoir 902 includes a composition including at least one of anultraviolet-A absorbing agent, an ultraviolet-B absorbing agent, and anultraviolet-C absorbing agent. In an embodiment, the reservoir 902includes a composition including at least one of sulisobenzone orthioctic acid. In an embodiment, the reservoir 902 includes acomposition including at least one of 2-phenylbenzimidazole-5-sulfonicacid, cinnamic acid, ferrulic acid, salicylic acid, or methoxycinnamicacid.

FIGS. 10A and 10B show an example of a method 1000 of inhibiting amicrobial colonization of an implanted or at least partially implantedcatheter device 102. At 1010, the method 1000 includes generating anevanescent electromagnetic field proximate one or more regions of atleast one of an outer surface 106 or an inner surface 108 of a bodystructure 104 defining at least one fluid-flow passageway of the atleast partially implanted catheter device 102 based on an automaticallydetected spectral parameter associated with a region proximate the atleast one of the outer surface 106 or the inner surface 108 of the bodystructure 104 defining the at least one fluid-flow passageway 110.

At 1012, generating the evanescent electromagnetic field includesgenerating a spatially patterned evanescent electromagnetic field. At1014, generating the evanescent electromagnetic field includesgenerating a spatially patterned evanescent electromagnetic field havingat least a first region and a second region, the second region having atleast one of a polarization, an intensity, a phase, an amplitude, apulse frequency, or a spectral power distribution different from thefirst region. At 1016, generating the evanescent electromagnetic fieldincludes generating a temporally patterned evanescent electromagneticfield. At 1018, generating the evanescent electromagnetic field includesgenerating a temporally patterned evanescent electromagnetic fieldhaving at least a first-in-time pattern and a second-in-time pattern,the second-in-time pattern having at least one of a polarization, anintensity, an amplitude, a phase, a wave vector (k), a pulse frequency,or a spectral power distribution different from the first-in-timepattern.

At 1020, generating the evanescent electromagnetic field includesgenerating a spatially patterned evanescent electromagnetic fieldproximate the one or more surface regions of the catheter device 102based on a detected fluorescence. At 1022, generating the evanescentelectromagnetic field includes generating an interference pattern viatwo or more evanescent electromagnetic fields proximate the one or moresurface regions of the catheter device 102 based on a detectedfluorescence. At 1024, generating the evanescent electromagnetic fieldincludes generating a spatially patterned evanescent electromagneticfield proximate the one or more surface regions of the catheter device102 based on a detected impedance. At 1026, generating the evanescentelectromagnetic field includes generating a spatially patternedevanescent electromagnetic field proximate the one or more surfaceregions of the catheter device 102 based on a detected opticalreflectance. At 1028, generating the evanescent electromagnetic fieldincludes generating a spatially patterned evanescent electromagneticfield proximate the one or more surface regions of the catheter device102 based on a detected heat transfer.

At 1030, generating the evanescent electromagnetic field includesgenerating a spatially patterned evanescent electromagnetic fieldproximate the one or more surface regions of the catheter device 102based on a detected metabolic product associated with a biofilm. At1032, generating the evanescent electromagnetic field includesgenerating a spatially patterned evanescent electromagnetic fieldproximate the one or more surface regions of the catheter device 102based on a detected radiation associated with a biofilm. At 1034,generating the evanescent electromagnetic field includes generating aspatially patterned evanescent electromagnetic field proximate the oneor more surface regions of the catheter device 102 in response to achange to a refractive index property of a plasmon supporting surfaceregion. At 1036, generating the evanescent electromagnetic fieldincludes generating a spatially patterned evanescent electromagneticfield proximate the one or more surface regions of the catheter device102 based on a detected acoustic wave associated with changes in abiological sample proximate at least one of the outer surface 106 or theinner surface 108 of the body structure 104. At 1038, generating theevanescent electromagnetic field includes generating a spatiallypatterned evanescent electromagnetic field proximate the one or moresurface regions of the catheter device 102 based on a detecteddifferential optical absorption associated with a biological sampleproximate at least one of the outer surface 106 or the inner surface 108of the body structure 104.

At 1040, generating the evanescent electromagnetic field includesgenerating a spatially patterned evanescent electromagnetic fieldproximate one or more surface regions of the catheter device 102determined to have a microbial colonization. At 1042, generating theevanescent electromagnetic field includes generating a spatiallypatterned evanescent electromagnetic field at a dose sufficient tomodulate a microbial colonization proximate a surface of the catheterdevice 102. At 1044, generating the evanescent electromagnetic fieldincludes generating a spatially patterned evanescent electromagneticfield at a dose sufficient to modulate microbial activity proximate asurface of the at least partially implanted catheter device 102.

FIG. 11 shows an example of a method 1100 of modulating microbialactivity proximate a surface of an at least partially implanted catheterdevice 102.

At 1110, the method 1100 includes generating a spatially patternedevanescent electromagnetic field proximate one or more surface regionsof the at least partially implanted catheter device 102 based on adetected change to a refractive index property associated with the oneor more surface regions of the at least partially implanted catheter. At1112, generating the spatially patterned evanescent electromagneticfield includes providing an evanescent electromagnetic field of a dosesufficient to modulate a microbial colonization process proximate one ormore surface regions of the at least partially implanted catheterexhibiting a change to a refractive index property. At 1114, generatingthe spatially patterned evanescent electromagnetic field includespropagating an electromagnetic energy stimulus along one or moreelectromagnetic energy waveguides 202 on at least one of the one or moresurface regions of the at least partially implanted catheter, the one ormore electromagnetic energy waveguides 202 configured to generate anevanescent electromagnetic field proximate a surface of the one or moreelectromagnetic energy waveguides 202.

At 1116, generating the spatially patterned evanescent electromagneticfield includes generating at least a first evanescent electromagneticfield and a second evanescent electromagnetic field proximate a surfaceof the one or more electromagnetic energy waveguides 202. In anembodiment, the second evanescent electromagnetic field includes atleast one of a polarization, an intensity, an amplitude, a phase, a wavevector (k), a pulse frequency, or a spectral power distributiondifferent from the first evanescent electromagnetic field.

At 1118, generating the spatially patterned evanescent electromagneticfield includes propagating an electromagnetic energy stimulus along oneor more electromagnetic energy waveguides 202 proximate one or moresurface regions of the at least partially implanted catheter exhibitinga change to a refractive index property. At 1120, generating thespatially patterned evanescent electromagnetic field includespropagating an electromagnetic energy stimulus along one or moresubstantially total-internal-reflection waveguides proximate one or moresurface regions of the at least partially implanted catheter exhibitinga change to a refractive index property. At 1122, generating thespatially patterned evanescent electromagnetic field includes generatingan evanescent electromagnetic field on two or more surface regions ofthe at least partially implanted catheter device 102, the evanescentelectromagnetic field of a dose sufficient to modulate a microbialcolonization process at the two or more surface regions of the at leastpartially implanted catheter device 102.

FIG. 12 shows an example of a method 1200. At 1210, the method 1200includes selectively energizing a plurality of regions proximate asurface of an implanted portion of a catheter device 102 via one or moreenergy-emitting components including one or more energy emitters 220 andat least one computing device 230 in response to real-time detectedinformation associated with a biological sample within one or moreregions proximate the surface of the implanted portion of the catheterdevice 102. Non-limiting examples of energy-emitting components includeelectric circuits, electrical conductors, electrodes (e.g., nano- andmicro-electrodes, patterned-electrodes, electrode arrays (e.g.,multi-electrode arrays, micro-fabricated multi-electrode arrays,patterned-electrode arrays, or the like), electrocautery electrodes, orthe like), cavity resonators, conducting traces, ceramic patternedelectrodes, electro-mechanical components, lasers, quantum dots, laserdiodes, light-emitting diodes (e.g., organic light-emitting diodes,polymer light-emitting diodes, polymer phosphorescent light-emittingdiodes, microcavity light-emitting diodes, high-efficiency UVlight-emitting diodes, or the like), arc flashlamps, incandescentemitters, transducers, heat sources, continuous wave bulbs, a quantumdot, ultrasound emitting elements, ultrasonic transducers, thermalenergy emitting elements, or the like.

At 1212, selectively energizing the plurality of regions includesenergetically interrogating those regions determined to have a microbialcolonization based on the real-time detected information. At 1214,selectively energizing the plurality of regions includes energeticallyinterrogating those regions determined to have a microbial colonizationwith a temporally patterned sterilizing-energy stimulus. At 1216,selectively energizing the plurality of regions includes energeticallyinterrogating those regions determined to have a microbial colonizationwith a spatially patterned sterilizing-energy stimulus.

At 1218, selectively energizing the plurality of regions includesenergetically interrogating those regions determined to have a microbialcolonization based on the real-time detected change to a refractiveindex property. At 1220, selectively energizing the plurality of regionsincludes energetically interrogating one or more regions proximate atleast one of an inner surface or an outer surface of the implantedportion of a catheter determined to have a microbial colonization basedon the real-time detected information. At 1222, selectively energizingthe plurality of regions includes directing an emitted energy stimulusvia one or more selectively actuatable energy waveguides 202 a to one ormore regions determined to have a microbial colonization. At 1224,selectively energizing the plurality of regions includes controllablybending one or more portions of an optical waveguide to controllablyemit light from one or more portions of a surface of the opticalwaveguide.

At 1226, selectively energizing the plurality of regions includesenergetically interrogating the one or more regions proximate thesurface of the implanted portion of the catheter device 102 with anelectromagnetic energy stimulus having a peak emission wavelengthranging from about 100 nanometers to about 400 nanometers. At 1228,selectively energizing the plurality of regions includes energeticallyinterrogating the one or more regions proximate the surface of theimplanted portion of the catheter device 102 with an electromagneticenergy stimulus having a peak emission wavelength ranging from about 100nanometers to about 320 nanometers.

At 1230, selectively energizing the plurality of regions includesenergetically interrogating the one or more regions proximate thesurface of the implanted portion of the catheter device 102 with anelectromagnetic energy stimulus having a peak emission wavelengthranging from about 280 nanometers to about 320 nanometers. At 1232,selectively energizing the plurality of regions includes energeticallyinterrogating the one or more regions proximate the surface of theimplanted portion of the catheter device 102 with an energy stimulushaving an average integrated flux of less than about 80 milli-joules persquare centimeter.

At 1234, selectively energizing the plurality of regions includesenergetically interrogating the one or more regions proximate thesurface of the implanted portion of the catheter device 102 withelectrical energy. At 1236, selectively energizing the plurality ofregions includes energetically interrogating the one or more regionsproximate the surface of the implanted portion of the catheter device102 with ultrasonic energy. At 1238, selectively energizing theplurality of regions includes energetically interrogating the one ormore regions proximate the surface of the implanted portion of thecatheter device 102 with thermal energy.

At 1240, selectively energizing the plurality of regions includesenergetically interrogating the one or more regions proximate thesurface of the implanted portion of the catheter device 102 with anenergy stimulus having an average integrated flux of less than about 35milli-joules per square centimeter. At 1242, selectively energizing theplurality of regions includes energetically interrogating the one ormore regions proximate the surface of the implanted portion of thecatheter device 102 with an energy stimulus having an average integratedflux of less than about 15 milli joules per square centimeter. At 1244,selectively energizing the plurality of regions includes energeticallyinterrogating the one or more regions proximate the surface of theimplanted portion of the catheter device 102 with an energy stimulushaving an average energy density ranging from about 15 milli-joules persquare centimeter to about less than about 80 milli-joules per squarecentimeter.

At 1250, the method 1200 includes determining a microbial colonizationscore in response to real-time detected information. At 1260, the method1200 includes energetically interrogating the one or more regionsproximate the surface of the implanted portion of the catheter device102 based on the determined microbial colonization score.

FIG. 13 shows an example of a method 1300 of a method of inhibitingbiofilm formation in a catheter device 102.

At 1310, the method 1300 includes actuating one or more selectivelyactuatable energy waveguides 202 a of a catheter device 102 in responseto an in vivo detected change in a refractive index parameter associatedwith a biological sample proximate an outer surface or an inner surfaceof the catheter device 102.

At 1312, actuating the one or more selectively actuatable energywaveguides 202 a includes energizing one or more computing devices 230to provide a control signal to actuate at least one of the one or moreselectively actuatable energy waveguides 202 a between an opticallytransmissive state and an optically non-transmissive state.

At 1314, actuating the one or more selectively actuatable energywaveguides 202 a includes causing at least one of the one or moreselectively actuatable energy waveguides 202 a to emit a sterilizingenergy stimulus based on a target change in the refractive indexparameter.

At 1316, actuating the one or more selectively actuatable energywaveguides 202 a includes propagating electromagnetic energy in at leastone of the one or more selectively actuatable energy waveguides 202 ahaving a portion proximate the outer surface 106 or the inner surface108 of the catheter device 102 having a threshold level change to an arefractive index parameter.

At 1320, the method 1300 includes providing a spatially patterned energystimulus to one or more regions proximate the outer surface or the innersurface of the catheter device 102.

At 1322, providing the spatially patterned energy stimulus includesproviding a spatially patterned energy stimulus having at least a firstregion and a second region different from the first region. In anembodiment, the first regions comprises one of a spatially patternedelectromagnetic energy stimulus, a spatially patterned electrical energystimulus, a spatially patterned ultrasonic energy stimulus, or aspatially patterned thermal energy stimulus, or the second regioncomprises a different one of a spatially patterned electromagneticenergy stimulus, a spatially patterned electrical energy stimulus, aspatially patterned ultrasonic energy stimulus, or a spatially patternedthermal energy stimulus.

At 1324, providing the spatially patterned energy stimulus includesproviding an illumination pattern comprising at least a first region anda second region. In an embodiment, the second region having at least oneof an emission intensity, an emission phase, an emission polarization,or an emission wavelength different from the first region. At 1326,providing the spatially patterned energy stimulus includes applying avoltage to two or more regions proximate at least one of the outersurface or the inner surface of the catheter device 102, the voltage ofa dose sufficient to exceed a nominal dielectric strength of a cellplasma membrane. At 1328, providing the spatially patterned energystimulus includes concurrently or sequentially providing at least afirst energy stimulus and a second energy stimulus the second energystimulus different from the first energy stimulus. In an embodiment, thefirst energy stimulus comprises one of an electromagnetic energystimulus, an electrical energy stimulus, an ultrasonic energy stimulus,or a thermal energy stimulus, and the second energy stimulus comprises adifferent one of an electromagnetic energy stimulus, an electricalenergy stimulus, an ultrasonic energy stimulus, or a thermal energystimulus.

FIG. 14 shows an example of a method 1400 of method of inhibitingbiofilm formation. At 1410, the method 1400 includes actuating one ormore surface regions of a catheter device 102 between at least a firstwettability state and a second wettability state in response to adetected event associate with a microbial colonization proximate the oneor more surface regions of a catheter device 102. At 1412, actuating theone or more surface regions of the catheter device 102 includesirradiating a photoactive coating with optical energy to change asurface functionality. At 1414, actuating the one or more surfaceregions of the catheter device 102 includes electrostatically changing asurface morphology of the one or more surface regions. At 1416,actuating the one or more surface regions of the catheter device 102includes applying an electric potential to the one or more surfaceregions of a sufficient strength and duration to affect a liquid/solidinterface fraction. At 1418, actuating the one or more surface regionsof the catheter device 102 includes applying an electric potential tothe one or more surface regions of a sufficient strength and duration toactuate a surface morphology change in the one or more surface regions.

At 1420, actuating the one or more surface regions of the catheterdevice 102 includes applying an electric potential to a conductivepolymer thin film laminate having a plurality of movable polymermicrostructures. In an embodiment, the electric potential is sufficientto displace a plurality of movable polymer microstructures relative toan outer surface of the conductive polymer thin film laminate. At 1422,actuating the one or more surface regions of the catheter device 102includes electro-chemically switching between the first wettabilitystate and the second wettability state in the presence of an ultravioletenergy. At 1424, actuating the one or more surface regions of thecatheter device 102 includes UV-manipulating the one or more surfaceregions between the first wettability state and the second wettabilitystate. At 1426, actuating the one or more surface regions of thecatheter device 102 includes photo-chemically switching the one or moresurface regions between a substantially hydrophobic state and asubstantially hydrophilic state. At 1428, actuating the one or moresurface regions of the catheter device 102 includes electricallyactuating the one or more surface regions between a substantiallyhydrophobic state and a substantially hydrophilic state

At 1430, actuating the one or more surface regions of the catheterdevice 102 includes UV-manipulating at least one ZnO nano-rod film,coating, or material between the first wettability state and the secondwettability state. At 1432, actuating the one or more surface regions ofthe catheter device 102 includes energetically controllably actuatingthe one or more surface regions between a substantially hydrophobicstate and a substantially hydrophilic state. At 1434, actuating the oneor more surface regions of the catheter device 102 includesenergetically controllably actuating the one or more surface regionsbetween at least a first hydrophilic state and a second hydrophilicstate. At 1436, actuating the one or more surface regions of thecatheter device 102 includes energetically controllably actuating theone or more surface regions between a hydrophobic state and ahydrophilic state. At 1438, actuating the one or more surface regions ofthe catheter device 102 includes switching the one or more surfaceregions between a zwitterionic state and a non-zwitterionic state.

FIG. 15 shows an example of a method 1500 of inhibiting a microbialcolonization of a surface of a catheter device 102.

At 1510, the method 1500 includes selectively energizing one or moreregions proximate at least one of an outer surface 106 or an innersurface 108 of the implanted portion of the catheter device 102 via oneor more energy-emitting components. In an embodiment, the methodincludes selectively energizing one or more regions proximate at leastone of an outer surface 106 or an inner surface 108 of an implantedportion of the catheter device 102 via one or more energy-emittingcomponents in response to an automatically detected measurand associatedwith biological sample proximate at least one of the outer surface orthe inner surface of the implanted portion of the catheter device 102.At 1512, selectively energizing the one or more regions includesdelivering an electromagnetic energy stimulus to one or more regionsproximate the catheter device 102 determined to have an infectious agentpresence, the electromagnetic energy stimulus at a dose sufficient tomodulate an activity of the infectious agent. At 1514, selectivelyenergizing the one or more regions includes delivering at least one ofan electromagnetic energy stimulus, an electrical energy stimulus, anultrasonic energy stimulus, or a thermal energy stimulus in response toautomatically detected measurand associated with biological sampleproximate the at least one of the outer surface or the inner surface ofthe implanted portion of the catheter device 102.

At 1516, selectively energizing the one or more regions includesdelivering at least a first energy stimulus and a second energy stimulusto the one or more regions. In an embodiment, the second energy stimulushaving at least one of an emission intensity, an emission phase, anemission polarization, or an emission wavelength different from thefirst energy stimulus. At 1518, selectively energizing the one or moreregions includes concurrently or sequentially delivering at least afirst energy stimulus to a first region and a second energy stimulus toa second region. At 1520, selectively energizing the one or more regionsincludes concurrently or sequentially delivering at least a firstspatially patterned energy stimulus to a first region and a secondspatially patterned energy stimulus to a second region. At 1522,selectively energizing the one or more regions includes delivering atemporally patterned energy stimulus to the one or more regions. At1524, selectively energizing the one or more regions includesconcurrently or sequentially delivering a first energy stimulus to atleast a first region and a second energy stimulus to at least a secondregion. In an embodiment, the first energy stimulus comprises one of anelectromagnetic energy stimulus, an electrical energy stimulus, anultrasonic energy stimulus, or a thermal energy stimulus, and the secondenergy stimulus comprises a different one of an electromagnetic energystimulus, an electrical energy stimulus, an ultrasonic energy stimulus,or a thermal energy stimulus.

At 1530, the method 1500 includes delivering an active agent compositionto the one or more regions proximate the catheter device 102 via one ormore active agent assemblies 900. In an embodiment, the method includesdelivering an active agent composition to the one or more regionsproximate the catheter device 102 via one or more active agentassemblies 900 in response to an automatically detected measurandassociated with biological sample proximate the catheter device 102. At1532, delivering the active agent composition includes delivering anantimicrobial agent composition at a dose sufficient to attenuate anactivity of the infectious agent in response to automatically detectedmeasurand associated with the biological sample. At 1534, delivering theactive agent composition includes delivering an energy-activatableantimicrobial agent composition including at least one photoactiveagent, or a metabolic precursor thereof. At 1536, delivering the activeagent composition includes delivering an energy-activatableantimicrobial agent composition including at least one X-ray absorber.At 1538, delivering the active agent composition includes delivering anenergy-activatable antimicrobial agent composition including at leastone radiation absorber. At 1540, delivering the active agent compositionincludes delivering an energy-activatable antimicrobial agentcomposition including at least one active agent that selectively targetsbacteria. At 1542, delivering the active agent composition includesdelivering a superoxide-forming composition.

At 1544, delivering the active agent composition includes delivering theactive agent composition prior to selectively energizing the one or moreregions. In an embodiment, the method includes selectively energizingone or more regions proximate at least one of an outer surface 106 or aninner surface 108 of the implanted portion of the catheter device 102via one or more energy-emitting components, and delivering an activeagent composition to the one or more regions proximate at least one ofan outer surface 106 or an inner surface 108 of the implanted portion ofthe catheter device 102 via one or more active agent assemblies, inresponse to an automatically detected measurand associated withbiological sample proximate at least one of the outer surface or theinner surface of the implanted portion of the catheter device 102.

FIG. 16 shows an example of a method 1600. At 1610, the method 1600includes concurrently or sequentially delivering to one or more regionsproximate a surface of a catheter device 102 a spatially patternedsterilizing energy stimulus via a plurality of independently activatableultraviolet energy delivering substrates 802. In an embodiment, theindependently activatable ultraviolet energy delivering substrates 802are configured to independently activate in response to a real-timedetected measurand associated with a biological sample within the one ormore regions proximate the surface of the catheter device 102. At 1612,concurrently or sequentially delivering to one or more regions proximatethe surface of the catheter device 102 the spatially patternedsterilizing energy stimulus includes delivering a temporally patternedevanescent electromagnetic field stimulus having at least afirst-in-time pattern and a second-in-time pattern. In an embodiment,the second-in-time pattern includes at least one of a polarization, anintensity, an amplitude, a phase, a wave vector (k), a pulse frequency,or a spectral power distribution different from the first-in-timepattern.

FIG. 17 shows an example of a method 1700. At 1710, the method 1700includes concurrently or sequentially delivering to one or more regionsproximate a surface of a catheter device 102 a temporally patternedsterilizing energy stimulus via a plurality of independently activatableultraviolet energy delivering substrates 802 configured to independentlyactivate in response to a real-time detected measurand associated withat least one of temporal metabolite information or spatial metaboliteinformation associated with a biological sample within the one or moreregions proximate the surface of the catheter device 102.

FIG. 18 shows an example of a method 1800. At 1810, the method 1800includes automatically comparing one or more characteristicscommunicated from an implanted catheter device 102 to stored referencedata, the one or more characteristics including at least one ofinformation associated with a microbial colonization proximate an outersurface or an inner surface of the implanted catheter device 102,information associated with an infection marker detected proximate anouter surface or an inner surface of the implanted catheter device 102,or information associated with a sample (e.g., a fluid, a biologicalsample, or the like) received within one or more fluid-flow passagewaysof the implanted catheter device 102. At 1812, automatically comparingthe one or more characteristics communicated from an implanted catheterdevice 102 to stored reference data includes comparing, via circuitryforming part of the implanted catheter device 102, one or morecharacteristics communicated from an implanted catheter device 102 tostored reference data.

At 1820, the method 1800 includes initiating a treatment protocol basedat least in part on the comparison. At 1822, initiating the treatmentprotocol includes generating a spatially patterned evanescentelectromagnetic field proximate the at least one of the outer surfaceand the inner surface of implanted catheter device 102 based at least inpart on the comparison. At 1824, initiating the treatment protocolincludes selectively energizing one or more regions proximate at leastone of an outer surface 106 or an inner surface 108 of the implantedshunt device via one or more energy-emitters based at least in part onthe comparison. At 1826, initiating the treatment protocol includesactuating one or more selectively actuatable energy waveguides 202 a ofthe implanted catheter device 102 based at least in part on thecomparison indicative of the presence of an infection proximate theimplanted catheter device 102. At 1828, initiating the treatmentprotocol includes delivering an effective dose of optical energy atwhich a cell preferentially undergoes apoptosis compared to necrosis.

At 1830, initiating the treatment protocol includes delivering aneffective dose of thermal energy at which a cell preferentiallyundergoes apoptosis compared to necrosis. At 1832, initiating thetreatment protocol includes delivering an ultraviolet radiation at adose sufficient to induce program cell death. At 1834, initiating thetreatment protocol includes delivering a dose of an ultravioletradiation based at least in part on the comparison indicating a presenceof an infectious agent near or on the implanted catheter device 102. At1836, initiating the treatment protocol includes delivering anelectromagnetic energy stimulus of a character and for a sufficient timeto induce apoptosis without substantially inducing necrosis of aninfectious agent proximate at least one of the outer surface or theinner surface of the implanted catheter device 102. At 1838, initiatingthe treatment protocol includes concurrently or sequentially deliveringtwo or more energy stimuli to at least one of the outer surface or theinner surface of the implanted catheter device 102 based at least inpart on a comparison indicating a presence of a microbial event near oron the implanted catheter device 102. At 1840, initiating the treatmentprotocol includes activating an authorization protocol, activating anauthentication protocol, activating an energy stimulus protocol,activating an active agent delivery protocol, or activating an infectionsterilization protocol based at least in part on the comparison.

At 1850, the method 1800 includes selectively energizing one or moreregions proximate the surface on the implanted portion of the catheterdevice 102 via one or more energy-emitting components based at least inpart on the comparison. At 1860, the method 1800 includes selectivelyenergizing one or more regions proximate the surface on the implantedportion of the catheter device 102 via one or more selectivelyactuatable energy waveguides configured to direct an emitted energystimulus to one or more regions proximate at least one of the outersurface 106 or the inner surface 108 of the body structure 104. At 1870,the method 1800 includes selectively energizing one or more regionsproximate the surface on the implanted portion of the catheter device102 determined to have a microbial colonization based at least in parton the comparison.

FIG. 19 shows an example of a method 1900. At 1910, the method 1900includes electronically comparing one or more characteristicscommunicated from an implanted catheter device 102 to stored referencedata, the one or more characteristics including at least one of an invivo detected microbial colonization presence proximate a surface of thecatheter device 102, an in vivo real-time detected infection markerpresence proximate a surface of the catheter device 102, in vivodetected measurand associated with a biofilm-specific tag, and areal-time obtained measurand associated with a microbial colonizationpresence proximate the catheter device 102. At 1920, the method 1900includes initiating a treatment protocol based at least in part on thecomparison.

FIG. 20 shows an example of a method 2000 of inhibiting biofilmformation in catheter device 102. At 2010, the method 2000 includesacoustically modulating one or more internally reflecting opticalwaveguides so as to partially emit an electromagnetic energy propagatingwithin the one or more internally reflecting optical waveguides throughat least one of an outer surface 106 or an inner surface 108 of thecatheter device 102. At 2012, acoustically modulating the one or moreinternally reflecting optical waveguides includes applying an acousticenergy stimulus to the one or more internally reflecting opticalwaveguides of a character and for a sufficient duration to affect atleast one of an index of refraction and a physical dimension of the oneor more internally reflecting optical waveguides. At 2014, acousticallymodulating the one or more internally reflecting optical waveguidesincludes acoustically modifying an index of refraction of at least oneof the one or more internally reflecting optical waveguides so as tomodulate an electromagnetic energy propagating within the one or moretotal-internal-reflection waveguides. At 2016, acoustically modulatingthe one or more internally reflecting optical waveguides includesdeforming at least one of the one or more internally reflecting opticalwaveguides in response to an acoustic stimulus. In an embodiment, theacoustic stimulus is of a character and for a duration sufficient tocause the at least one of the one or more internally reflecting opticalwaveguides to emit a portion of the electromagnetic energy internallyreflected within.

At 2020, the method 2000 includes selectively actuating one or moreoptical waveguides so as to partially emit an electromagnetic energypropagating within the one or more optical waveguides through at leastone of an outer surface 106 or an inner surface 108 of the catheterdevice 102 in response to real-time detected information associated witha microbial colonization in one or more regions proximate at least oneof an outer surface or an inner surface of the catheter device 102.

FIG. 21 shows an example of a method 2100. At 2110, the method 2100includes detecting a measurand associated with a microbial presenceproximate at a surface of a catheter device 102 using an interrogationenergy having a first peak emission wavelength. At 2120, the method 1900includes delivering a sterilizing stimulus having a second peak emissionwavelength different from the first peak emission wavelength to one ormore regions proximate the surface on the catheter device 102 inresponse to the detecting a measurand.

FIG. 22 shows an example of a method 2200. At 2210, the method 2200includes real-time monitoring of a plurality of portions of a catheterdevice 102 for a microbial colonization by detecting spectralinformation associated with an interrogating stimulus having a firstpeak emission wavelength. At 2220, the method 2200 includes delivering asterilizing stimulus having a second peak emission wavelength differentfrom the first peak emission wavelength to select ones of the pluralityof portions of the catheter device 102 based on a determined microbialcolonization score.

FIG. 23 shows an example of a method 2300. At 2310, the method 2300includes real-time monitoring at least one of an outer surface 106 or aninner surface 108 of an indwelling portion of a catheter device 102 fora microbial colonization by detecting spectral information associatedwith an interrogating stimulus having a first peak emission wavelength,the interrogating stimulus delivered to one or more region proximate theat least one of the outer surface or the inner surface of an indwellingportion of a catheter device 102.

At 2320, the method 2300 includes determining a microbial colonizationscore for the one or more region proximate the at least one of the outersurface or the inner surface of an indwelling portion of a catheterdevice 102 in response to detecting spectral information. At 2330, themethod 2300 includes selective-delivering a sterilizing stimulus havinga second peak emission wavelength different from the first peak emissionwavelength to at least one of the one or more region proximate the atleast one of the outer surface or the inner surface of an indwellingportion of a catheter device 102 based on a determined microbialcolonization score.

FIG. 24 shows an example of a method 2400. At 2410, the method 2400includes delivering an ultraviolet energy absorbing composition to oneor more regions proximate a surface of a catheter device 102 prior todelivering a patterned energy stimulus to the one or more regions basedon a detected measurand associated with biological sample proximate theone or more regions. At 2420, the method 2400 includes delivering asterilizing ultraviolet energy stimulus to select ones of the one ormore regions based on the detected measurand.

FIG. 25 shows an example of a method 2500. At 2510, the method 2500includes delivering an ultraviolet energy absorbing composition to oneor more regions proximate at least one of an outer surface 106 or aninner surface 108 of an implanted portion of a catheter device 102 priorto selectively energizing the one or more regions in response to areal-time detected spectral information associated with a microbialpresence within the one or more regions.

At least a portion of the devices and/or processes described herein canbe integrated into a data processing system. A data processing systemgenerally includes one or more of a system unit housing, a video displaydevice, memory such as volatile or non-volatile memory, processors suchas microprocessors or digital signal processors, computational entitiessuch as operating systems, drivers, graphical user interfaces, andapplications programs, one or more interaction devices (e.g., a touchpad, a touch screen, an antenna, etc.), and/or control systems includingfeedback loops and control motors (e.g., feedback for detecting positionand/or velocity, control motors for moving and/or adjusting componentsand/or quantities). A data processing system can be implementedutilizing suitable commercially available components, such as thosetypically found in data computing/communication and/or networkcomputing/communication systems.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely examples, and that in fact, many other architectures can beimplemented that achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “associated with” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermedial components. Likewise, any two components soassociated can also be viewed as being “operably connected”, or“operably coupled,” to each other to achieve the desired functionality,and any two components capable of being so associated can also be viewedas being “operably coupleable,” to each other to achieve the desiredfunctionality. Specific examples of operably coupleable include, but arenot limited to, physically mateable and/or physically interactingcomponents, and/or wirelessly interactable, and/or wirelesslyinteracting components, and/or logically interacting, and/or logicallyinteractable components.

In an embodiment, one or more components may be referred to herein as“configured to,” “configurable to,” “operable/operative to,”“adapted/adaptable,” “able to,” “conformable/conformed to,” etc. Suchterms (e.g., “configured to”) can generally encompass active-statecomponents and/or inactive-state components and/or standby-statecomponents, unless context requires otherwise.

The foregoing detailed description has set forth various embodiments ofthe devices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by the reader that each function and/or operation within suchblock diagrams, flowcharts, or examples can be implemented, individuallyand/or collectively, by a wide range of hardware, software, firmware, orvirtually any combination thereof. Further, the use of “Start,” “End,”or “Stop” blocks in the block diagrams is not intended to indicate alimitation on the beginning or end of any functions in the diagram. Suchflowcharts or diagrams may be incorporated into other flowcharts ordiagrams where additional functions are performed before or after thefunctions shown in the diagrams of this application. In an embodiment,several portions of the subject matter described herein is implementedvia Application Specific Integrated Circuits (ASICs), Field ProgrammableGate Arrays (FPGAs), digital signal processors (DSPs), or otherintegrated formats. However, some aspects of the embodiments disclosedherein, in whole or in part, can be equivalently implemented inintegrated circuits, as one or more computer programs running on one ormore computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, the mechanisms ofthe subject matter described herein are capable of being distributed asa program product in a variety of forms, and that an illustrativeembodiment of the subject matter described herein applies regardless ofthe particular type of signal-bearing medium used to actually carry outthe distribution. Non-limiting examples of a signal-bearing mediuminclude the following: a recordable type medium such as a floppy disk, ahard disk drive, a Compact Disc (CD), a Digital Video Disk (DVD), adigital tape, a computer memory, etc.; and a transmission type mediumsuch as a digital and/or an analog communication medium (e.g., a fiberoptic cable, a waveguide, a wired communications link, a wirelesscommunication link (e.g., transmitter, receiver, transmission logic,reception logic, etc.), etc.).

While particular aspects of the present subject matter described hereinhave been shown and described, it will be apparent to the reader that,based upon the teachings herein, changes and modifications can be madewithout departing from the subject matter described herein and itsbroader aspects and, therefore, the appended claims are to encompasswithin their scope all such changes and modifications as are within thetrue spirit and scope of the subject matter described herein. Ingeneral, terms used herein, and especially in the appended claims (e.g.,bodies of the appended claims) are generally intended as “open” terms(e.g., the term “including” should be interpreted as “including but notlimited to,” the term “having” should be interpreted as “having atleast,” the term “includes” should be interpreted as “includes but isnot limited to,” etc.). Further, if a specific number of an introducedclaim recitation is intended, such an intent will be explicitly recitedin the claim, and in the absence of such recitation no such intent ispresent. For example, as an aid to understanding, the following appendedclaims may contain usage of the introductory phrases “at least one” and“one or more” to introduce claim recitations. However, the use of suchphrases should not be construed to imply that the introduction of aclaim recitation by the indefinite articles “a” or “an” limits anyparticular claim containing such introduced claim recitation to claimscontaining only one such recitation, even when the same claim includesthe introductory phrases “one or more” or “at least one” and indefinitearticles such as “a” or “an” (e.g., “a” and/or “an” should typically beinterpreted to mean “at least one” or “one or more”); the same holdstrue for the use of definite articles used to introduce claimrecitations. In addition, even if a specific number of an introducedclaim recitation is explicitly recited, such recitation should typicallybe interpreted to mean at least the recited number (e.g., the barerecitation of “two recitations,” without other modifiers, typicallymeans at least two recitations, or two or more recitations).Furthermore, in those instances where a convention analogous to “atleast one of A, B, and C, etc.” is used, in general such a constructionis intended in the sense of the convention (e.g., “a system having atleast one of A, B, and C” would include but not be limited to systemsthat have A alone, B alone, C alone, A and B together, A and C together,B and C together, and/or A, B, and C together, etc.). In those instanceswhere a convention analogous to “at least one of A, B, or C, etc.” isused, in general such a construction is intended in the sense of theconvention (e.g., “a system having at least one of A, B, or C” wouldinclude but not be limited to systems that have A alone, B alone, Calone, A and B together, A and C together, B and C together, and/or A,B, and C together, etc.). Typically a disjunctive word and/or phrasepresenting two or more alternative terms, whether in the description,claims, or drawings, should be understood to contemplate thepossibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, the operations recited thereingenerally may be performed in any order. Also, although variousoperational flows are presented in a sequence(s), it should beunderstood that the various operations may be performed in orders otherthan those that are illustrated, or may be performed concurrently.Examples of such alternate orderings includes overlapping, interleaved,interrupted, reordered, incremental, preparatory, supplemental,simultaneous, reverse, or other variant orderings, unless contextdictates otherwise. Furthermore, terms like “responsive to,” “relatedto,” or other past-tense adjectives are generally not intended toexclude such variants, unless context dictates otherwise.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments are contemplated. The various aspects andembodiments disclosed herein are for purposes of illustration and arenot intended to be limiting, with the true scope and spirit beingindicated by the following claims.

What is claimed is:
 1. A method of inhibiting a microbial colonizationof a surface on an implanted portion of a catheter device, comprising:selectively energizing one or more regions proximate at least one of anouter surface or an inner surface of the implanted portion of thecatheter device via one or more energy-emitting components; anddelivering an active agent composition to the one or more regionsproximate at least one of the outer surface or the inner surface of theimplanted portion of the catheter device via one or more active agentassemblies, in response to an automatically detected measurandassociated with a biological sample proximate at least one of the outersurface or the inner surface of the implanted portion of the catheterdevice; wherein the selectively energizing the one or more regionsincludes delivering an electromagnetic energy stimulus to the one ormore regions proximate at least one of the outer surface or the innersurface of the implanted portion determined to have an infectious agentpresence, the electromagnetic energy stimulus at a dose sufficient tomodulate an activity of the infectious agent.
 2. A method of inhibitinga microbial colonization of a surface on an implanted portion of acatheter device, comprising: selectively energizing one or more regionsproximate at least one of an outer surface or an inner surface of theimplanted portion of the catheter device via one or more energy-emittingcomponents; and delivering an active agent composition to the one ormore regions proximate at least one of the outer surface or the innersurface of the implanted portion of the catheter device via one or moreactive agent assemblies, in response to an automatically detectedmeasurand associated with a biological sample proximate at least one ofthe outer surface or the inner surface of the implanted portion of thecatheter device; wherein the selectively energizing the one or moreregions includes delivering at least a first energy stimulus and asecond energy stimulus to the one or more regions, the second energystimulus having at least one of an emission intensity, an emissionphase, an emission polarization, or an emission wavelength differentfrom the first energy stimulus.
 3. A method of inhibiting a microbialcolonization of a surface on an implanted portion of a catheter device,comprising: selectively energizing one or more regions proximate atleast one of an outer surface or an inner surface of the implantedportion of the catheter device via one or more energy-emittingcomponents; and delivering an active agent composition to the one ormore regions proximate at least one of the outer surface or the innersurface of the implanted portion of the catheter device via one or moreactive agent assemblies, in response to an automatically detectedmeasurand associated with a biological sample proximate at least one ofthe outer surface or the inner surface of the implanted portion of thecatheter device; wherein the selectively energizing the one or moreregions includes concurrently or sequentially delivering at least afirst energy stimulus to a first region and a second energy stimulus toa second region.
 4. A method of inhibiting a microbial colonization of asurface on an implanted portion of a catheter device, comprising:selectively energizing one or more regions proximate at least one of anouter surface or an inner surface of the implanted portion of thecatheter device via one or more energy-emitting components; anddelivering an active agent composition to the one or more regionsproximate at least one of the outer surface or the inner surface of theimplanted portion of the catheter device via one or more active agentassemblies, in response to an automatically detected measurandassociated with a biological sample proximate at least one of the outersurface or the inner surface of the implanted portion of the catheterdevice; wherein the selectively energizing the one or more regionsincludes concurrently or sequentially delivering at least a firstspatially patterned energy stimulus to a first region and a secondspatially patterned energy stimulus to a second region.
 5. A method ofinhibiting a microbial colonization of a surface on an implanted portionof a catheter device, comprising: selectively energizing one or moreregions proximate at least one of an outer surface or an inner surfaceof the implanted portion of the catheter device via one or moreenergy-emitting components; and delivering an active agent compositionto the one or more regions proximate at least one of the outer surfaceor the inner surface of the implanted portion of the catheter device viaone or more active agent assemblies, in response to an automaticallydetected measurand associated with a biological sample proximate atleast one of the outer surface or the inner surface of the implantedportion of the catheter device; wherein the selectively energizing theone or more regions includes delivering a temporally patterned energystimulus to the one or more regions.
 6. A method of inhibiting amicrobial colonization of a surface on an implanted portion of acatheter device, comprising: selectively energizing one or more regionsproximate at least one of an outer surface or an inner surface of theimplanted portion of the catheter device via one or more energy-emittingcomponents; and delivering an active agent composition to the one ormore regions proximate at least one of the outer surface or the innersurface of the implanted portion of the catheter device via one or moreactive agent assemblies, in response to an automatically detectedmeasurand associated with a biological sample proximate at least one ofthe outer surface or the inner surface of the implanted portion of thecatheter device; wherein the selectively energizing the one or moreregions includes concurrently or sequentially delivering a first energystimulus to at least a first region and a second energy stimulus to atleast a second region, the first energy stimulus comprising one of anelectromagnetic energy stimulus, an electrical energy stimulus, anacoustic energy stimulus, or a thermal energy stimulus, and the secondenergy stimulus comprising a different one of an electromagnetic energystimulus, an electrical energy stimulus, an acoustic energy stimulus, ora thermal energy stimulus.
 7. A method of inhibiting a microbialcolonization of a surface on an implanted portion of a catheter device,comprising: selectively energizing one or more regions proximate atleast one of an outer surface or an inner surface of the implantedportion of the catheter device via one or more energy-emittingcomponents; and delivering an active agent composition to the one ormore regions proximate at least one of the outer surface or the innersurface of the implanted portion of the catheter device via one or moreactive agent assemblies, in response to an automatically detectedmeasurand associated with a biological sample proximate at least one ofthe outer surface or the inner surface of the implanted portion of thecatheter device; wherein the delivering the active agent compositionincludes delivering an antimicrobial agent composition at a dosesufficient to attenuate an activity of an infectious agent in responseto the automatically detected measurand associated with the biologicalsample.
 8. A method of inhibiting a microbial colonization of a surfaceon an implanted portion of a catheter device, comprising: selectivelyenergizing one or more regions proximate at least one of an outersurface or an inner surface of the implanted portion of the catheterdevice via one or more energy-emitting components; and delivering anactive agent composition to the one or more regions proximate at leastone of the outer surface or the inner surface of the implanted portionof the catheter device via one or more active agent assemblies, inresponse to an automatically detected measurand associated with abiological sample proximate at least one of the outer surface or theinner surface of the implanted portion of the catheter device; whereinthe delivering the active agent composition includes delivering anenergy-activatable antimicrobial agent composition including at leastone photoactive agent, or a metabolic precursor thereof.
 9. A method ofinhibiting a microbial colonization of a surface on an implanted portionof a catheter device, comprising: selectively energizing one or moreregions proximate at least one of an outer surface or an inner surfaceof the implanted portion of the catheter device via one or moreenergy-emitting components; and delivering an active agent compositionto the one or more regions proximate at least one of the outer surfaceor the inner surface of the implanted portion of the catheter device viaone or more active agent assemblies, in response to an automaticallydetected measurand associated with a biological sample proximate atleast one of the outer surface or the inner surface of the implantedportion of the catheter device; wherein the delivering the active agentcomposition includes delivering an energy-activatable antimicrobialagent composition including at least one X-ray absorber.
 10. A method ofinhibiting a microbial colonization of a surface on an implanted portionof a catheter device, comprising: selectively energizing one or moreregions proximate at least one of an outer surface or an inner surfaceof the implanted portion of the catheter device via one or moreenergy-emitting components; and delivering an active agent compositionto the one or more regions proximate at least one of the outer surfaceor the inner surface of the implanted portion of the catheter device viaone or more active agent assemblies, in response to an automaticallydetected measurand associated with a biological sample proximate atleast one of the outer surface or the inner surface of the implantedportion of the catheter device; wherein the delivering the active agentcomposition includes delivering an energy-activatable antimicrobialagent composition including at least one active agent that selectivelytargets bacteria.
 11. A method of inhibiting a microbial colonization ofa surface on an implanted portion of a catheter device, comprising:selectively energizing one or more regions proximate at least one of anouter surface or an inner surface of the implanted portion of thecatheter device via one or more energy-emitting components; anddelivering an active agent composition to the one or more regionsproximate at least one of the outer surface or the inner surface of theimplanted portion of the catheter device via one or more active agentassemblies, in response to an automatically detected measurandassociated with a biological sample proximate at least one of the outersurface or the inner surface of the implanted portion of the catheterdevice; wherein the delivering the active agent composition includesdelivering a superoxide-forming composition.